Trial Outcomes & Findings for Comparative Study of Ropivacaine and Ropivacaine With Dexmeditomedine in TAP Blocks (NCT NCT02472522)
NCT ID: NCT02472522
Last Updated: 2016-07-06
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
24 hours
Results posted on
2016-07-06
Participant Flow
The study was conducted between May 2015 to November 2015 in the Obstetrics and Gynaecology Operation Theater and Post-operative ward of the Tata Main Hospital, Jamshedpur, India.
Participant milestones
| Measure |
Ropivacaine
Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
|
Ropivacaine + Dexmedetomidine
Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block
Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparative Study of Ropivacaine and Ropivacaine With Dexmeditomedine in TAP Blocks
Baseline characteristics by cohort
| Measure |
Ropivacaine
n=50 Participants
Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block was performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
Ropivacaine: Patients satisfying inclusion criteria will received Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
|
Ropivacaine + Dexmedetomidine
n=50 Participants
Patients satisfying the inclusion criteria received Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block was performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block
Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.02 Years
STANDARD_DEVIATION 4.64 • n=5 Participants
|
28.66 Years
STANDARD_DEVIATION 4.53 • n=7 Participants
|
28.34 Years
STANDARD_DEVIATION 4.57 • n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
India
|
50 participants
n=5 Participants
|
50 participants
n=7 Participants
|
100 participants
n=5 Participants
|
|
Weight
|
64.08 Kilograms
STANDARD_DEVIATION 5.96 • n=5 Participants
|
65.68 Kilograms
STANDARD_DEVIATION 7.49 • n=7 Participants
|
64.88 Kilograms
STANDARD_DEVIATION 6.78 • n=5 Participants
|
|
Height of the patients
|
158.90 Centimeters
STANDARD_DEVIATION 4.53 • n=5 Participants
|
157.36 Centimeters
STANDARD_DEVIATION 15.77 • n=7 Participants
|
158.13 Centimeters
STANDARD_DEVIATION 11.57 • n=5 Participants
|
|
Duration of surgery
|
50.12 Minutes
STANDARD_DEVIATION 3.97 • n=5 Participants
|
50.00 Minutes
STANDARD_DEVIATION 4.35 • n=7 Participants
|
50.06 Minutes
STANDARD_DEVIATION 4.14 • n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: Number of patients who sought rescue analgesic within the first 24 hours postoperatively. Rest of the studied patients needed no rescue analgesic within the first 24 hours postoperatively.
Outcome measures
| Measure |
Ropivacaine
n=25 Participants
Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
|
Ropivacaine + Dexmedetomidine
n=14 Participants
Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block
Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block
|
|---|---|---|
|
The Time After the TAP Block When Rescue Analgesia Was First Sought
|
13.12 Hours
Standard Deviation 3.53
|
18.21 Hours
Standard Deviation 3.14
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: Only the mentioned number of patients needed analgesia within the first 24 hours postoperatively
Outcome measures
| Measure |
Ropivacaine
n=25 Participants
Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
|
Ropivacaine + Dexmedetomidine
n=14 Participants
Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block
Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block
|
|---|---|---|
|
Total Dose of Required Morphine in 24 Hours Postoperatively
|
8.16 Milligrams
Standard Deviation 2.94
|
6.21 Milligrams
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: 24 hoursOutcome measures
| Measure |
Ropivacaine
n=50 Participants
Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
|
Ropivacaine + Dexmedetomidine
n=50 Participants
Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block
Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block
|
|---|---|---|
|
Adverse Effects Like Pruritus, Nausea and Vomiting
Nausea
|
1 participants
|
0 participants
|
|
Adverse Effects Like Pruritus, Nausea and Vomiting
Vomiting
|
2 participants
|
1 participants
|
|
Adverse Effects Like Pruritus, Nausea and Vomiting
No adverse effect
|
47 participants
|
49 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Upto 60 minutesThe Mean Arterial Pressure (MAP) of the patients were recorded from the start of surgery up to 60 minutes at 5, 10, 20, 30, 40, 50, 60 mins. No surgery lasted more than 60 minutes.
Outcome measures
| Measure |
Ropivacaine
n=50 Participants
Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
|
Ropivacaine + Dexmedetomidine
n=50 Participants
Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block
Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block
|
|---|---|---|
|
Mean Arterial Pressure (MAP): Intraoperative Period
Baseline
|
76.84 millimeter of mercury (mmHg)
Standard Deviation 8.57
|
79.38 millimeter of mercury (mmHg)
Standard Deviation 10.40
|
|
Mean Arterial Pressure (MAP): Intraoperative Period
At 5 minutes
|
68.28 millimeter of mercury (mmHg)
Standard Deviation 7.90
|
66.38 millimeter of mercury (mmHg)
Standard Deviation 7.97
|
|
Mean Arterial Pressure (MAP): Intraoperative Period
At 10 minutes
|
67.42 millimeter of mercury (mmHg)
Standard Deviation 6.26
|
67.52 millimeter of mercury (mmHg)
Standard Deviation 8.62
|
|
Mean Arterial Pressure (MAP): Intraoperative Period
At 20 minutes
|
70.02 millimeter of mercury (mmHg)
Standard Deviation 7.24
|
68.98 millimeter of mercury (mmHg)
Standard Deviation 8.63
|
|
Mean Arterial Pressure (MAP): Intraoperative Period
At 30 minutes
|
72.46 millimeter of mercury (mmHg)
Standard Deviation 7.39
|
73.44 millimeter of mercury (mmHg)
Standard Deviation 8.68
|
|
Mean Arterial Pressure (MAP): Intraoperative Period
At 40 minutes
|
75.82 millimeter of mercury (mmHg)
Standard Deviation 7.93
|
77.76 millimeter of mercury (mmHg)
Standard Deviation 9.55
|
|
Mean Arterial Pressure (MAP): Intraoperative Period
At 50 minutes
|
76.98 millimeter of mercury (mmHg)
Standard Deviation 8.89
|
79.90 millimeter of mercury (mmHg)
Standard Deviation 10.67
|
|
Mean Arterial Pressure (MAP): Intraoperative Period
At 60 minutes
|
79.66 millimeter of mercury (mmHg)
Standard Deviation 10.10
|
84.02 millimeter of mercury (mmHg)
Standard Deviation 12.94
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 60 minutesThe Heart Rate of the patients were recorded from the start of surgery up to 60 minutes at 5, 10, 20, 30, 40, 50, 60 mins. No surgery lasted more than 60 minutes.
Outcome measures
| Measure |
Ropivacaine
n=50 Participants
Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
|
Ropivacaine + Dexmedetomidine
n=50 Participants
Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block
Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block
|
|---|---|---|
|
Heart Rate: Intraoperative Period
Baseline
|
85.64 beats/minute
Standard Deviation 7.75
|
86.76 beats/minute
Standard Deviation 9.54
|
|
Heart Rate: Intraoperative Period
At 5 minutes
|
94.52 beats/minute
Standard Deviation 10.68
|
98.20 beats/minute
Standard Deviation 11.54
|
|
Heart Rate: Intraoperative Period
At 10 minutes
|
96.60 beats/minute
Standard Deviation 11.92
|
97.02 beats/minute
Standard Deviation 11.75
|
|
Heart Rate: Intraoperative Period
At 20 minutes
|
93.84 beats/minute
Standard Deviation 10.35
|
93.28 beats/minute
Standard Deviation 10.46
|
|
Heart Rate: Intraoperative Period
At 30 minutes
|
91.08 beats/minute
Standard Deviation 8.71
|
90.06 beats/minute
Standard Deviation 9.99
|
|
Heart Rate: Intraoperative Period
At 40 minutes
|
87.96 beats/minute
Standard Deviation 8.46
|
88.68 beats/minute
Standard Deviation 10.24
|
|
Heart Rate: Intraoperative Period
At 50 minutes
|
86.60 beats/minute
Standard Deviation 8.84
|
87.52 beats/minute
Standard Deviation 10.17
|
|
Heart Rate: Intraoperative Period
At 60 minutes
|
86.74 beats/minute
Standard Deviation 9.44
|
88.50 beats/minute
Standard Deviation 11.28
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 hoursDuring the postoperative recovery, the level of motor block was assessed with Modified Bromage Scale 0 = no paralysis, able to flex hips/knees/ankles 1. = able to move knees, unable to raise extended legs 2. = able to flex ankles, unable to flex knees 3. = unable to move any part of the lower limb The time from subarachnoid block to complete disappearance of motor block (Bromage 0) was recorded in minutes.
Outcome measures
| Measure |
Ropivacaine
n=50 Participants
Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
|
Ropivacaine + Dexmedetomidine
n=50 Participants
Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block
Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block
|
|---|---|---|
|
Time to Complete Disappearance of Motor Block
|
171.06 minutes
Standard Deviation 5.51
|
170.34 minutes
Standard Deviation 14.62
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 hoursThe duration of sensory loss (from the subarachnoid block) at T10 level was assessed by pin-prick test by a sterile needle in minutes.
Outcome measures
| Measure |
Ropivacaine
n=50 Participants
Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
|
Ropivacaine + Dexmedetomidine
n=50 Participants
Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block
Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block
|
|---|---|---|
|
Duration of Sensory Loss at T10 Level
|
303.74 minutes
Standard Deviation 7.86
|
305.40 minutes
Standard Deviation 7.19
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 hoursThe Mean Arterial Pressure (MAP) of the patients were recorded after shifting from Operation Theater and at 1, 4, 8,12,18 and 24th hour after shifting to the postoperarive area.
Outcome measures
| Measure |
Ropivacaine
n=50 Participants
Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
|
Ropivacaine + Dexmedetomidine
n=50 Participants
Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block
Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block
|
|---|---|---|
|
Mean Arterial Pressure (MAP): Postoperative Period
On shifting
|
79.98 millimeter of mercury (mmHg)
Standard Deviation 10.13
|
83.80 millimeter of mercury (mmHg)
Standard Deviation 13.33
|
|
Mean Arterial Pressure (MAP): Postoperative Period
1 hour
|
80.14 millimeter of mercury (mmHg)
Standard Deviation 10.58
|
83.46 millimeter of mercury (mmHg)
Standard Deviation 12.13
|
|
Mean Arterial Pressure (MAP): Postoperative Period
4 hours
|
78.38 millimeter of mercury (mmHg)
Standard Deviation 9.72
|
82 millimeter of mercury (mmHg)
Standard Deviation 11.60
|
|
Mean Arterial Pressure (MAP): Postoperative Period
8 hours
|
78.06 millimeter of mercury (mmHg)
Standard Deviation 8.34
|
81.26 millimeter of mercury (mmHg)
Standard Deviation 10.65
|
|
Mean Arterial Pressure (MAP): Postoperative Period
12 hours
|
82.90 millimeter of mercury (mmHg)
Standard Deviation 10.64
|
80.84 millimeter of mercury (mmHg)
Standard Deviation 9.80
|
|
Mean Arterial Pressure (MAP): Postoperative Period
18 hours
|
83.94 millimeter of mercury (mmHg)
Standard Deviation 7.07
|
85.08 millimeter of mercury (mmHg)
Standard Deviation 13.89
|
|
Mean Arterial Pressure (MAP): Postoperative Period
24 hours
|
77.24 millimeter of mercury (mmHg)
Standard Deviation 5.64
|
79.46 millimeter of mercury (mmHg)
Standard Deviation 7.76
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 hoursThe Heart Rate of the patients were recorded after shifting from Operation Theater and at 1, 4, 8,12,18 and 24th hour after shifting to the postoperarive area.
Outcome measures
| Measure |
Ropivacaine
n=50 Participants
Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
|
Ropivacaine + Dexmedetomidine
n=50 Participants
Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block
Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block
|
|---|---|---|
|
Heart Rate: Postoperative
On shifting
|
84.92 beats/minute
Standard Deviation 13.90
|
88.52 beats/minute
Standard Deviation 12.59
|
|
Heart Rate: Postoperative
At 1 hour
|
86.74 beats/minute
Standard Deviation 9.56
|
86.50 beats/minute
Standard Deviation 12.09
|
|
Heart Rate: Postoperative
At 4 hours
|
83.50 beats/minute
Standard Deviation 8.07
|
82.54 beats/minute
Standard Deviation 10.01
|
|
Heart Rate: Postoperative
At 8 hours
|
81.46 beats/minute
Standard Deviation 9.11
|
81.14 beats/minute
Standard Deviation 10.00
|
|
Heart Rate: Postoperative
At 12 hours
|
85.26 beats/minute
Standard Deviation 13.48
|
83.18 beats/minute
Standard Deviation 8.03
|
|
Heart Rate: Postoperative
At 18 hours
|
80.88 beats/minute
Standard Deviation 10.44
|
81.60 beats/minute
Standard Deviation 15.52
|
|
Heart Rate: Postoperative
At 24 hours
|
78.82 beats/minute
Standard Deviation 6.59
|
79.14 beats/minute
Standard Deviation 6.64
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 hoursVisual Analogue Scale at rest (VAS-R) was used to assess Post-operative Pain at rest. Where: 0 = no Pain and 10 = Worst Imaginable Pain. They were Recorded on Shifting to Postoperative and Then at 1, 4, 8, 12, 18 and 24 Hour
Outcome measures
| Measure |
Ropivacaine
n=50 Participants
Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
|
Ropivacaine + Dexmedetomidine
n=50 Participants
Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block
Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block
|
|---|---|---|
|
Visual Analogue Scale at Rest (VAS-R)
On shifting to postoperative area
|
0.06 Units on a scale
Standard Deviation 0.31
|
0.00 Units on a scale
Standard Deviation 0.0
|
|
Visual Analogue Scale at Rest (VAS-R)
At 1 hour
|
0.36 Units on a scale
Standard Deviation 0.56
|
0.38 Units on a scale
Standard Deviation 0.53
|
|
Visual Analogue Scale at Rest (VAS-R)
At 4 hours
|
0.94 Units on a scale
Standard Deviation 0.65
|
0.96 Units on a scale
Standard Deviation 0.53
|
|
Visual Analogue Scale at Rest (VAS-R)
At 8 hours
|
1.46 Units on a scale
Standard Deviation 0.86
|
1.34 Units on a scale
Standard Deviation 0.74
|
|
Visual Analogue Scale at Rest (VAS-R)
At 12 hours
|
2.54 Units on a scale
Standard Deviation 1.49
|
1.66 Units on a scale
Standard Deviation 0.52
|
|
Visual Analogue Scale at Rest (VAS-R)
At 18 hours
|
2.74 Units on a scale
Standard Deviation 1.44
|
2.12 Units on a scale
Standard Deviation 0.72
|
|
Visual Analogue Scale at Rest (VAS-R)
At 24 hours
|
1.88 Units on a scale
Standard Deviation 0.38
|
1.78 Units on a scale
Standard Deviation 0.42
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 hoursVisual Analogue Scale on Coughing (VAS-C) Was Used to Assess Post-operative Pain on Coughing. Where: 0 = no Pain and 10 = Worst Imaginable Pain. They were Recorded on Shifting to Postoperative and Then at 1, 4, 8, 12, 18 and 24 Hour
Outcome measures
| Measure |
Ropivacaine
n=50 Participants
Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
|
Ropivacaine + Dexmedetomidine
n=50 Participants
Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block
Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block
|
|---|---|---|
|
Visual Analogue Scale on Coughing (VAS-C)
On shifting to postoperative area
|
0.24 Units on a scale
Standard Deviation 0.52
|
0.08 Units on a scale
Standard Deviation 0.27
|
|
Visual Analogue Scale on Coughing (VAS-C)
At 1 hour
|
1.12 Units on a scale
Standard Deviation 0.75
|
0.96 Units on a scale
Standard Deviation 0.57
|
|
Visual Analogue Scale on Coughing (VAS-C)
At 4 hours
|
1.58 Units on a scale
Standard Deviation 0.70
|
1.48 Units on a scale
Standard Deviation 0.54
|
|
Visual Analogue Scale on Coughing (VAS-C)
At 8 hours
|
2.22 Units on a scale
Standard Deviation 1.05
|
1.94 Units on a scale
Standard Deviation 0.65
|
|
Visual Analogue Scale on Coughing (VAS-C)
At 12 hours
|
3.42 Units on a scale
Standard Deviation 1.76
|
2.40 Units on a scale
Standard Deviation 0.64
|
|
Visual Analogue Scale on Coughing (VAS-C)
At 18 hours
|
3.52 Units on a scale
Standard Deviation 1.49
|
3.02 Units on a scale
Standard Deviation 0.82
|
|
Visual Analogue Scale on Coughing (VAS-C)
At 24 hours
|
2.62 Units on a scale
Standard Deviation 0.60
|
2.64 Units on a scale
Standard Deviation 0.52
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 hoursShort assessment of patient satisfaction score(SAPS) was assessed on a 5 point scale at the end of 24 hours on the quality of postoperative analgesia. where: 1. highly dissatisfied 2. dissatisfied 3. neither dissatisfied nor satisfied 4. satisfied 5. highly satisfied
Outcome measures
| Measure |
Ropivacaine
n=50 Participants
Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
|
Ropivacaine + Dexmedetomidine
n=50 Participants
Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block
Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block
|
|---|---|---|
|
Short Assessment of Patient Satisfaction Score (SAPS)
|
4.22 Units on a scale
Standard Deviation 0.93
|
4.70 Units on a scale
Standard Deviation 0.50
|
POST_HOC outcome
Timeframe: 24 hoursPercentage of patients needing rescue analgesic. Rescue analgesia was provided with 6 mg of intravenous morphine and additional doses of 3 mg at 10 minutes interval till VAS was less than 3 or the development of adverse effects such as nausea and/or vomiting, respiratory depression (SpO2 \<92%, ventilatory frequency rate \<10), or occurrence of deep sedation (eyes closed \>3 min, Ramsay Score RS \>2).
Outcome measures
| Measure |
Ropivacaine
n=50 Participants
Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
|
Ropivacaine + Dexmedetomidine
n=50 Participants
Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block
Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block
|
|---|---|---|
|
Percentage of Patients Needing Rescue Analgesic
|
50 percentage needing rescue analgesic
|
28 percentage needing rescue analgesic
|
Adverse Events
Ropivacaine
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Ropivacaine + Dexmedetomidine
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ropivacaine
n=50 participants at risk
Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
|
Ropivacaine + Dexmedetomidine
n=50 participants at risk
Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block
Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/50 • 1st 24 hours postoperatively
|
0.00%
0/50 • 1st 24 hours postoperatively
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
2/50 • 1st 24 hours postoperatively
|
2.0%
1/50 • 1st 24 hours postoperatively
|
Additional Information
Specialist, Anaesthesia & Critical Care
Tata Main Hospital, Jamshedpur, India
Phone: 91-9431166582
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place