Trial Outcomes & Findings for Bilateral Paravertebral Blockade (T7-10) vs. Incisional Local Anesthetic Administration for Pediatric Patients (NCT NCT01380834)
NCT ID: NCT01380834
Last Updated: 2017-11-20
Results Overview
The primary end-point of this research is the amount of dilaudid (ng/kg/min) administered via Patient Controlled Analgesia (PCA), 12 hours after administration of ropivacaine 0.5% /normal saline in paravertebral space and administration of normal saline/ropivacaine 0.5% at all four laparoscopic ports.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
84 participants
Primary outcome timeframe
12 hrs after the blocks were done
Results posted on
2017-11-20
Participant Flow
Participant milestones
| Measure |
Treatment Group
Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.
treatment group: Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.
|
Placebo Group
Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.
control group: Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
42
|
|
Overall Study
COMPLETED
|
41
|
42
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Treatment Group
Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.
treatment group: Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.
|
Placebo Group
Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.
control group: Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Bilateral Paravertebral Blockade (T7-10) vs. Incisional Local Anesthetic Administration for Pediatric Patients
Baseline characteristics by cohort
| Measure |
Treatment Group
n=42 Participants
Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.
treatment group: Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.
|
Placebo Group
n=42 Participants
Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.
control group: Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
42 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
14.5 years
n=5 Participants
|
14 years
n=7 Participants
|
14 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=5 Participants
|
42 participants
n=7 Participants
|
84 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 hrs after the blocks were doneThe primary end-point of this research is the amount of dilaudid (ng/kg/min) administered via Patient Controlled Analgesia (PCA), 12 hours after administration of ropivacaine 0.5% /normal saline in paravertebral space and administration of normal saline/ropivacaine 0.5% at all four laparoscopic ports.
Outcome measures
| Measure |
Treatment Group
n=41 Participants
Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.
treatment group: Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.
|
Placebo Group
n=42 Participants
Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.
control group: Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.
|
|---|---|---|
|
Opioids Consumption Via PCA
|
107.29 ng/kg/min
Standard Deviation 20.23
|
100.17 ng/kg/min
Standard Deviation 46.77
|
SECONDARY outcome
Timeframe: 24 hrs after blocks were done or until the patient is dischargedThe VAS (Visual Analog Scale, 0 mm "no pain", to 100 mm," the worst pain possible ") is used to assess postoperative pain for patients. Postoperative pain scores will be assessed and compared at 4, 8, 12, 18 and 24 hr after paravertebral block.
Outcome measures
| Measure |
Treatment Group
n=41 Participants
Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.
treatment group: Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.
|
Placebo Group
n=42 Participants
Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.
control group: Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.
|
|---|---|---|
|
Postoperative Pain Scores Assessed Using Visual Analog Scale (VAS).
4h VAS
|
42.68 units on a scale
Standard Deviation 27.48
|
38.95 units on a scale
Standard Deviation 26.94
|
|
Postoperative Pain Scores Assessed Using Visual Analog Scale (VAS).
8h VAS
|
46.69 units on a scale
Standard Deviation 30.15
|
37.67 units on a scale
Standard Deviation 27.88
|
|
Postoperative Pain Scores Assessed Using Visual Analog Scale (VAS).
12h VAS
|
43.88 units on a scale
Standard Deviation 29.16
|
36.07 units on a scale
Standard Deviation 27.94
|
|
Postoperative Pain Scores Assessed Using Visual Analog Scale (VAS).
18h VAS
|
42.62 units on a scale
Standard Deviation 31.22
|
35.73 units on a scale
Standard Deviation 27.59
|
|
Postoperative Pain Scores Assessed Using Visual Analog Scale (VAS).
24h VAS
|
42.17 units on a scale
Standard Deviation 28.73
|
29.98 units on a scale
Standard Deviation 25.91
|
SECONDARY outcome
Timeframe: 24 hrs after blocks were done or until the patient is dischargedOther secondary end points will total amount of fentanyl (mcg/kg), dilaudid (mcg/kg), oxycodone (mg/kg) and morphine (mg/kg) (after conversion of above opioids to morphine based on opioids potency) used at 24 hours postoperatively (or until the patient is discharged, if sooner).
Outcome measures
| Measure |
Treatment Group
n=41 Participants
Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.
treatment group: Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.
|
Placebo Group
n=42 Participants
Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.
control group: Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.
|
|---|---|---|
|
Opioid Consumption
|
0.73 mg/kg
Standard Deviation 0.32
|
0.71 mg/kg
Standard Deviation 0.26
|
Adverse Events
Treatment Group
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Placebo Group
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment Group
n=41 participants at risk
Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.
treatment group: Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.
|
Placebo Group
n=42 participants at risk
Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.
control group: Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
58.5%
24/41
|
47.6%
20/42
|
|
Gastrointestinal disorders
Emesis
|
34.1%
14/41
|
35.7%
15/42
|
|
Skin and subcutaneous tissue disorders
Itching
|
31.7%
13/41
|
19.0%
8/42
|
|
Injury, poisoning and procedural complications
Back Pain
|
7.3%
3/41
|
2.4%
1/42
|
|
Injury, poisoning and procedural complications
Vascular Puncture
|
2.4%
1/41
|
9.5%
4/42
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place