Trial Outcomes & Findings for The Use of Intraperitoneal Ropivacaine in Bariatric Bypass Surgery (NCT NCT02154763)
NCT ID: NCT02154763
Last Updated: 2019-03-19
Results Overview
Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).
COMPLETED
PHASE3
120 participants
0-1 hours post operatively
2019-03-19
Participant Flow
Participant milestones
| Measure |
Intraperitoneal Normal Saline
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
|
Overall Study
COMPLETED
|
46
|
46
|
|
Overall Study
NOT COMPLETED
|
14
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Use of Intraperitoneal Ropivacaine in Bariatric Bypass Surgery
Baseline characteristics by cohort
| Measure |
Intraperitoneal Normal Saline
n=46 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=46 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Mean BMI
|
45.82 kg/m^2
STANDARD_DEVIATION 6.57 • n=5 Participants
|
48.57 kg/m^2
STANDARD_DEVIATION 6.07 • n=7 Participants
|
47.195 kg/m^2
STANDARD_DEVIATION 6.32 • n=5 Participants
|
|
Age, Continuous
|
45.1 Years
STANDARD_DEVIATION 9.44 • n=5 Participants
|
44.4 Years
STANDARD_DEVIATION 9.42 • n=7 Participants
|
44.75 Years
STANDARD_DEVIATION 9.43 • n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
46 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
History of Pain Syndromes
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
History of Asthma
|
6 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
History of Cardiovascular Disease
|
24 participants
n=5 Participants
|
15 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
History of Arthritis
|
22 participants
n=5 Participants
|
22 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
On Diabetic Medications
|
18 participants
n=5 Participants
|
12 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
On Pain Medications
|
22 participants
n=5 Participants
|
20 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Previous Caesarean section
|
12 participants
n=5 Participants
|
9 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Previous Laparoscopic Cholecystectomy
|
9 participants
n=5 Participants
|
13 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Prior Surgery
|
44 participants
n=5 Participants
|
44 participants
n=7 Participants
|
88 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0-1 hours post operativelyPopulation: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. The analysis was done and revised by our Statistician
Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=42 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=45 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
0-1 h Postoperative Pain Level
|
3.9762 units on a scale
Standard Deviation 2.5191
|
4.3149 units on a scale
Standard Deviation 2.1074
|
PRIMARY outcome
Timeframe: 1-2 hours post operativelyPopulation: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. The analysis was done and revised by our Statistician
Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=41 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=45 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
1-2 h Postoperative Pain Level
|
3.5307 units on a scale
Standard Deviation 1.6086
|
3.6911 units on a scale
Standard Deviation 1.522
|
PRIMARY outcome
Timeframe: 2-4 hours post operativelyPopulation: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. The analysis was done and revised by our Statistician
Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=43 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=46 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
2-4 Hours Post Operative Pain Level
|
3.2733 units on a scale
Standard Deviation 1.3186
|
3.1978 units on a scale
Standard Deviation 1.1836
|
PRIMARY outcome
Timeframe: 4-8 hours post operativelyPopulation: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. The analysis was done and revised by our Statistician
Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=43 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=45 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
4-8 Hours Post Operative Pain Level
|
3.6507 units on a scale
Standard Deviation 1.7729
|
3.8387 units on a scale
Standard Deviation 1.6156
|
PRIMARY outcome
Timeframe: 8-12 hours post operativelyPopulation: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. The analysis was done and revised by our Statistician
Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=44 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=45 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
8-12 Hours Post Operative Pain Level
|
3.7955 units on a scale
Standard Deviation 2.0667
|
3.9056 units on a scale
Standard Deviation 1.6866
|
PRIMARY outcome
Timeframe: 12-16 hours post operativelyPopulation: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. The analysis was done and revised by our Statistician
Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=43 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=45 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
12-16 Hours Post Operative Pain Level
|
3.4419 units on a scale
Standard Deviation 2.2152
|
3.9444 units on a scale
Standard Deviation 1.9283
|
PRIMARY outcome
Timeframe: 16-20 hours post operativelyPopulation: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. The analysis was done and revised by our Statistician
Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=46 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=46 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
16-20 Hours Post Operative Pain Level
|
3.4186 units on a scale
Standard Deviation 1.899
|
3.8081 units on a scale
Standard Deviation 1.6071
|
PRIMARY outcome
Timeframe: 20-24 hours post operativelyPopulation: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. The analysis was done and revised by our Statistician
Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=44 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=43 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
20-24 Hours Post Operative Pain Level
|
3.2386 units on a scale
Standard Deviation 1.6548
|
3.4651 units on a scale
Standard Deviation 1.5976
|
PRIMARY outcome
Timeframe: 24-32 hours post operativelyPopulation: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients being discharged from hospital early or refusing reading; varying the number of results obtained in a specific time frame. The analysis was done and revised by our Statistician
Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=37 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=38 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
24-32 Hours Post Operative Pain Level
|
3.2568 units on a scale
Standard Deviation 1.7858
|
3.1974 units on a scale
Standard Deviation 1.9951
|
PRIMARY outcome
Timeframe: 32-40 hours post operativelyPopulation: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients being discharged from hospital early or refusing reading; varying the number of results obtained in a specific time frame. The analysis was done and revised by our Statistician
Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=35 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=38 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
32-40 Hours Post Operative Pain Level
|
2.8143 units on a scale
Standard Deviation 1.7409
|
2.9955 units on a scale
Standard Deviation 1.9079
|
PRIMARY outcome
Timeframe: 40-48 hours post operativelyPopulation: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients being discharged from hospital early or refusing reading; varying the number of results obtained in a specific time frame. The analysis was done and revised by our Statistician
Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=31 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=33 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
40-48 Hours Post Operative Pain Level
|
2.7661 units on a scale
Standard Deviation 1.9842
|
2.9394 units on a scale
Standard Deviation 1.3507
|
SECONDARY outcome
Timeframe: 1 hours post operativelyPopulation: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. The analysis was done and revised by our Statistician
Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point.
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=42 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=45 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
1h Peak Expiratory Flow (PEF) Score
|
202.9 L/min
Standard Deviation 99.9948
|
200.3 L/min
Standard Deviation 88.4809
|
SECONDARY outcome
Timeframe: 2 hours post operativelyPopulation: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. The analysis was done and revised by our Statistician
Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point.
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=42 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=45 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
2h Peak Expiratory Flow (PEF) Score
|
243 L/min
Standard Deviation 104.1
|
239.8 L/min
Standard Deviation 84.9128
|
SECONDARY outcome
Timeframe: 4 hours post operativelyPopulation: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. The analysis was done and revised by our Statistician
Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point.
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=43 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=46 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
4h Peak Expiratory Flow (PEF) Score
|
251.9 L/min
Standard Deviation 93.5798
|
256.1 L/min
Standard Deviation 77.5092
|
SECONDARY outcome
Timeframe: 8 hours post operativelyPopulation: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. The analysis was done and revised by our Statistician
Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point.
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=43 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=45 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
8h Peak Expiratory Flow (PEF) Score
|
250.9 L/min
Standard Deviation 81.9403
|
255.3 L/min
Standard Deviation 86.4081
|
SECONDARY outcome
Timeframe: 12 hours post operativelyPopulation: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. The analysis was done and revised by our Statistician
Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point.
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=44 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=45 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
12h Peak Expiratory Flow (PEF) Score
|
240 L/min
Standard Deviation 88.7052
|
241.6 L/min
Standard Deviation 73.7843
|
SECONDARY outcome
Timeframe: 16 hours post operativelyPopulation: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. The analysis was done and revised by our Statistician
Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point.
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=44 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=46 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
16h Peak Expiratory Flow (PEF) Score
|
233.4 L/min
Standard Deviation 86.6212
|
242.2 L/min
Standard Deviation 76.4464
|
SECONDARY outcome
Timeframe: 20 hours post operativelyPopulation: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. The analysis was done and revised by our Statistician
Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point.
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=44 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=43 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
20h Peak Expiratory Flow (PEF) Score
|
246 L/min
Standard Deviation 97.9415
|
245.1 L/min
Standard Deviation 66.3817
|
SECONDARY outcome
Timeframe: 24 hours post operativelyPopulation: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. The analysis was done and revised by our Statistician
Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point.
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=44 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=43 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
24h Peak Expiratory Flow (PEF) Score
|
255.2 L/min
Standard Deviation 92.1195
|
253.8 L/min
Standard Deviation 73.1017
|
SECONDARY outcome
Timeframe: 32 hours post operativelyPopulation: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. The analysis was done and revised by our Statistician
Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point.
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=37 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=37 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
32h Peak Expiratory Flow (PEF) Score
|
256.62 L/min
Standard Deviation 95.183
|
265.5 L/min
Standard Deviation 84.941
|
SECONDARY outcome
Timeframe: 40 hours post operativelyPopulation: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. The analysis was done and revised by our Statistician
Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point.
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=35 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=37 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
40h Peak Expiratory Flow (PEF) Score
|
255.3 L/min
Standard Deviation 96.6315
|
265.8 L/min
Standard Deviation 81.654
|
SECONDARY outcome
Timeframe: 48 hours post operativelyPopulation: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point.
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=16 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=19 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
48h Peak Expiratory Flow (PEF) Score
|
285.3 L/min
Standard Deviation 97.1162
|
285.3 L/min
Standard Deviation 84.6803
|
SECONDARY outcome
Timeframe: Post operative day 1Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. The analysis was done and revised by our Statistician
6-Minute walk distance (6MWD)-Defined as the distance in (m) an individual is able to walk a long a flat 30 m walkway over six--minute period, with breaks as required. walk testing has been validated in the obese population, clinically significant differences occur when distances of at least 80m occur. 0 m would be the worst possible value for this outcome and the higher the number achieved in the six-minute duration the better (Better outcome)
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=42 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=46 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
6 Minute Walking Distance Post Operative Day 1 (POD1)
|
205.8 Meters
Standard Deviation 94.3378
|
182.4 Meters
Standard Deviation 97.1065
|
SECONDARY outcome
Timeframe: Post operative day 2Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
6-Minute walk distance (6MWD)-Defined as the distance in (m) an individual is able to walk a long a flat 30 m walkway over six--minute period, with breaks as required. walk testing has been validated in the obese population, clinically significant differences occur when distances of at least 80m occur. 0 m would be the worst possible value for this outcome and the higher the number achieved in the six-minute duration the better (Better outcome)
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=36 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=38 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
6 Minute Walking Distance Post Operative Day 2 (POD2)
|
260 Meters
Standard Deviation 87.8853
|
217.2 Meters
Standard Deviation 101.7
|
SECONDARY outcome
Timeframe: Post operative day 1Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
40-item questionnaire provides a global score(Minimum-score 40, Maximum-Score 200, Higher score represent better Quality of recovery of participant in both global and subscores) subscores(summed to total the global score) across five dimensions explained below, in all categories minimum score is 1, maximum score of 5 for each question.unit is scores on a scale for all questions. Emotional\_State:9 questions subscore can range between 9-45 Physical\_Comfort:12 questions, subscore range between 12-60 Psychological Support:7 questions, subscore range between 7-35 Physical\_Independence:5 questions, subscore range between 5-25 Pain:7 questions, subscore range between 5-25 Questionnaire has two parts A and B, In part A, a score of 1 represents the answer of "None of the time (Poor)"and 5 represents the answer"All of the time (Excellent)"Part B, score of 1 represents the answer"All of the time (Excellent)" and 5 represents"None of the time (Poor)
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=46 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=46 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
Postoperative Day 1 Quality of Recovery Questionnaire (QR-40)
|
163 Scores on a scale
Standard Deviation 16.4944
|
163.6 Scores on a scale
Standard Deviation 14.6931
|
SECONDARY outcome
Timeframe: 0-1 hours post operativelyPopulation: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
The amount in mg of Tylenol administered to the patient
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=45 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=46 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
0-1 h Postoperative Tylenol Consumption
|
72.2222 mg
Standard Deviation 206.6
|
49.2391 mg
Standard Deviation 192.7
|
SECONDARY outcome
Timeframe: 0-1 hours post operativelyPopulation: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
The amount in mg of Ketorolac administered to patient
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=45 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=46 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
0-1 h Postoperative Ketorolac Consumption
|
5 mg
Standard Deviation 7.8335
|
6.413 mg
Standard Deviation 8.6707
|
SECONDARY outcome
Timeframe: 0-1 hours post operativelyPopulation: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
The amount in mg of Dilaudid administered to patient
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=45 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=46 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
0-1 h Postoperative Dilaudid Consumption
|
1008.9 mg
Standard Deviation 951.5
|
925 mg
Standard Deviation 641.8
|
SECONDARY outcome
Timeframe: 0-1 h Postoperative Tramadol consumptionPopulation: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
The amount in mg of Tramadol administered to patient
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=45 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=46 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
0-1 h Postoperative Tramadol Consumption
|
3.3333 mg
Standard Deviation 12.6131
|
2.1739 mg
Standard Deviation 10.3092
|
SECONDARY outcome
Timeframe: 0-1 hours post operativelyPopulation: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
The amount in mcg of Fentanyl administered to patient
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=45 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=46 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
0-1 h Postoperative Fentanyl Consumption
|
45.5556 mcg
Standard Deviation 43.722
|
42.9348 mcg
Standard Deviation 45.5409
|
SECONDARY outcome
Timeframe: 1-2 hours post operativelyPopulation: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
The amount in mg of Tylenol administered to patient
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=45 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=46 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
1-2 h Postoperative Tylenol Consumption
|
144.2 mg
Standard Deviation 272.9
|
141.3 mg
Standard Deviation 271.1
|
SECONDARY outcome
Timeframe: 1-2 hours post operativelyPopulation: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
The amount in mg of Ketorolac administered to patient
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=45 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=46 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
1-2 h Postoperative Ketorolac Consumption
|
2.3333 mg
Standard Deviation 6.3604
|
2.3913 mg
Standard Deviation 5.3478
|
SECONDARY outcome
Timeframe: 1-2 hours post operativelyPopulation: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
The amount in mg of Dilaudid administered to patient
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=45 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=46 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
1-2 h Postoperative Dilaudid Consumption
|
291.1 mg
Standard Deviation 488.9
|
489.1 mg
Standard Deviation 582.8
|
SECONDARY outcome
Timeframe: 1-2 hours post operativelyPopulation: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
The amount in mg of Tramadol administered to patient
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=45 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=46 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
1-2 h Postoperative Tramadol Consumption
|
9.4444 mg
Standard Deviation 19.43
|
8.6957 mg
Standard Deviation 19.1612
|
SECONDARY outcome
Timeframe: 1-2 hours post operativelyPopulation: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
The amount in mcg of Fentanyl administered to patient
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=45 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=46 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
1-2 h Postoperative Fentanyl Consumption
|
10 mcg
Standard Deviation 17.9962
|
7.6087 mcg
Standard Deviation 16.5576
|
SECONDARY outcome
Timeframe: 2-4 hours post operativelyPopulation: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
The amount in mg of Tylenol administered to patient
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=45 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=46 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
2-4 h Postoperative Tylenol Consumption
|
216.4 mg
Standard Deviation 309.6
|
240.2 mg
Standard Deviation 317.2
|
SECONDARY outcome
Timeframe: 2-4 hours post operativelyPopulation: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
The amount in mg of Ketorolac administered to patient
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=45 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=46 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
2-4 h Postoperative Ketorolac Consumption
|
3.2222 mg
Standard Deviation 6.9213
|
1.0087 mg
Standard Deviation 3.7421
|
SECONDARY outcome
Timeframe: 2-4 hours post operativelyPopulation: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
The amount in mg of Dilaudid administered to patient
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=45 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=46 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
2-4 h Postoperative Dilaudid Consumption
|
415.6 mg
Standard Deviation 604.5
|
484.8 mg
Standard Deviation 707.4
|
SECONDARY outcome
Timeframe: 2-4 hours post operativelyPopulation: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
The amount in mg of Tramadol administered to patient
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=45 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=46 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
2-4 h Postoperative Tramadol Consumption
|
12.2222 mg
Standard Deviation 21.7307
|
15.2174 mg
Standard Deviation 23.2608
|
SECONDARY outcome
Timeframe: 2-4 hours post operativelyPopulation: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
The amount in mcg of Fentanyl administered to patient
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=45 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=46 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
2-4 h Postoperative Fentanyl Consumption
|
4.4444 mcg
Standard Deviation 13.3663
|
33.1522 mcg
Standard Deviation 191.6
|
SECONDARY outcome
Timeframe: 4-12 hours post operativelyPopulation: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
The amount in mg of Tylenol administered to patient
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=45 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=46 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
4-12 h Postoperative Tylenol Consumption
|
1140.9 mg
Standard Deviation 441.5
|
1187 mg
Standard Deviation 394.9
|
SECONDARY outcome
Timeframe: 4-12 hours post operativelyPopulation: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
The amount in mg of Ketorolac administered to patient
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=45 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=46 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
4-12 h Postoperative Ketorolac Consumption
|
6.8889 mg
Standard Deviation 11.2961
|
5.2174 mg
Standard Deviation 9.065
|
SECONDARY outcome
Timeframe: 4-12 hours post operativelyPopulation: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
The amount in mg of Tramadol administered to patient
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=45 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=46 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
4-12 h Postoperative Tramadol Consumption
|
81.1111 mg
Standard Deviation 38.86
|
85.8696 mg
Standard Deviation 31.0252
|
SECONDARY outcome
Timeframe: 4-12 hours post operativelyPopulation: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
The amount in mg of Dilaudid administered to patient
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=45 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=46 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
4-12 h Postoperative Dilaudid Consumption
|
2000 mg
Standard Deviation 1714.1
|
1830.4 mg
Standard Deviation 2018.1
|
SECONDARY outcome
Timeframe: 12-24 hours post operativelyPopulation: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
The amount in mg of Tylenol administered to patient
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=45 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=46 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
12-24 h Postoperative Tylenol Consumption
|
1921.1 mg
Standard Deviation 414.7
|
1837 mg
Standard Deviation 460.7
|
SECONDARY outcome
Timeframe: 12-24 hours post operativelyPopulation: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
The amount in mg of Ketorolac administered to patient
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=45 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=46 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
12-24 h Postoperative Ketorolac Consumption
|
6.3333 mg
Standard Deviation 11.3016
|
5.5435 mg
Standard Deviation 10.1778
|
SECONDARY outcome
Timeframe: 12-24 hours post operativelyPopulation: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
The amount in mg of Tramadol administered to patient
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=45 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=46 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
12-24 h Postoperative Tramadol Consumption
|
141.1 mg
Standard Deviation 38.86
|
138 mg
Standard Deviation 31.9458
|
SECONDARY outcome
Timeframe: 12-24 hours post operativelyPopulation: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
The amount in mg of Dilaudid administered to patient
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=45 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=46 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
12-24 h Postoperative Dilaudid Consumption
|
2066.7 mg
Standard Deviation 1923.5
|
2760.9 mg
Standard Deviation 3085.3
|
SECONDARY outcome
Timeframe: 24-48 hours post operativelyPopulation: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
The amount in mg of Tylenol administered to patient
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=45 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=46 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
24-48 h Postoperative Tylenol Consumption
|
3033.3 mg
Standard Deviation 1239.5
|
2826.1 mg
Standard Deviation 1330.1
|
SECONDARY outcome
Timeframe: 24-48 hours post operativelyPopulation: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
The amount in mg of Ketorolac administered to patient
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=45 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=46 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
24-48 h Postoperative Ketorolac Consumption
|
2.3333 mg
Standard Deviation 7.8044
|
3.2609 mg
Standard Deviation 8.8955
|
SECONDARY outcome
Timeframe: 24-48 hours post operativelyPopulation: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
The amount in mg of Tramadol administered to patient
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=45 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=46 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
24-48 h Postoperative Tramadol Consumption
|
216.7 mg
Standard Deviation 97.1175
|
215.2 mg
Standard Deviation 101.6
|
SECONDARY outcome
Timeframe: 24-48 hours post operativelyPopulation: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
The amount in mg of Dilaudid administered to patient
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=45 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=46 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
24-48 h Postoperative Dilaudid Consumption
|
2933.3 mg
Standard Deviation 3563.7
|
3000 mg
Standard Deviation 3489.7
|
SECONDARY outcome
Timeframe: Post operative day 7-10Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
40-item questionnaire provides a global score(Minimum-score 40,Maximum-Score 200, Higher score represent better Quality of recovery of participant in both global and subscores) subscores(summed to total the global score) across five dimensions explained below, in all categories minimum score is 1,maximum score of 5 for each question.unit is scores on a scale for all questions. Emotional\_State:9 questions subscore can range between 9-45 Physical\_Comfort:12 questions, subscore range between 12-60 Psychological Support:7 questions, subscore range between 7-35 Physical\_Independence:5 questions, subscore range between 5-25 Pain:7 questions,subscore range between 5-25 Questionnaire has two parts A and B, In part A, a score of 1 represents the answer of "None of the time (Poor)"and 5 represents the answer"All of the time (Excellent)"Part B, score of 1 represents the answer"All of the time (Excellent)" and 5 represents"None of the time (Poor)
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=41 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=42 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
Postoperative Day 7-10 Quality of Recovery Questionnaire (QR-40)
|
183.5 Scores on a scale
Standard Deviation 14.1829
|
182.7 Scores on a scale
Standard Deviation 14.0707
|
SECONDARY outcome
Timeframe: Post operative day 7-10 (Follow-up Clinic)Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Missing Appointment or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
6-Minute walk distance (6MWD)-Defined as the distance in (m) an individual is able to walk a long a flat 30 m walkway over six--minute period, with breaks as required. walk testing has been validated in the obese population, clinically significant differences occur when distances of at least 80m occur. 0 m would be the worst possible value for this outcome and the higher the number achieved in the six-minute duration the better (Better outcome)
Outcome measures
| Measure |
Intraperitoneal Normal Saline
n=41 Participants
Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection.
|
Intraperitoneal Ropivacaine
n=44 Participants
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
|
|---|---|---|
|
6 Minute Walking Distance Post Operative Day 7-10 (POD 7-10)
|
373.3 meters
Standard Deviation 68.1203
|
352.4 meters
Standard Deviation 90.2276
|
Adverse Events
Control
Intraperitoneal Ropivacaine
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place