Trial Outcomes & Findings for Trans-incisional vs Laparoscopic Guided Rectus Sheath Block for Pediatric Single Incision Laparoscopic Cholecystectomy (NCT NCT02494336)
NCT ID: NCT02494336
Last Updated: 2021-01-22
Results Overview
Using the Wong-Baker FACES Pain Rating Scale (WBFPRS). The WBFPRS is a visual pain rating scale in which the participant looks at pictures of faces depicting levels of pain and chooses the one that most closely resembles their own pain. The scale ranges from 0 "no hurt" to 10 "Hurts Worst."
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
48 participants
Primary outcome timeframe
5 days
Results posted on
2021-01-22
Participant Flow
Participant milestones
| Measure |
Trans-incisional Rectus Sheath Block
rectus sheath block under direct visualization through the umbilical incision by the attending surgeon
Trans-incisional rectus sheath block: After removal of the gallbladder, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon. This will be done after closure of the fascial incision but prior to closure of the skin incision.
Ropivacaine: Ropivacaine is a long-acting local anesthetic. It has been shown to be effective for peripheral nerve, caudal, and lumbar/thoracic epidural blocks and produce less motor blockade than bupivacaine after caudal administration. It will be the local anesthetic used to perform the rectus sheath block for both arms.
|
Laparoscopic Guided Rectus Sheath Block
rectus sheath block under direct laparoscopic visualization by the attending surgeon
Laparoscopic guided rectus sheath block: After removal of the gallbladder, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally) will be administered intra-abdominally under direct laparoscopic visualization into the rectus sheath bilaterally by the attending surgeon.
Ropivacaine: Ropivacaine is a long-acting local anesthetic. It has been shown to be effective for peripheral nerve, caudal, and lumbar/thoracic epidural blocks and produce less motor blockade than bupivacaine after caudal administration. It will be the local anesthetic used to perform the rectus sheath block for both arms.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
|
Overall Study
COMPLETED
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Trans-incisional Rectus Sheath Block
n=24 Participants
rectus sheath block under direct visualization through the umbilical incision by the attending surgeon
Trans-incisional rectus sheath block: After removal of the gallbladder, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon. This will be done after closure of the fascial incision but prior to closure of the skin incision.
Ropivacaine: Ropivacaine is a long-acting local anesthetic. It has been shown to be effective for peripheral nerve, caudal, and lumbar/thoracic epidural blocks and produce less motor blockade than bupivacaine after caudal administration. It will be the local anesthetic used to perform the rectus sheath block for both arms.
|
Laparoscopic Guided Rectus Sheath Block
n=24 Participants
rectus sheath block under direct laparoscopic visualization by the attending surgeon
Laparoscopic guided rectus sheath block: After removal of the gallbladder, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally) will be administered intra-abdominally under direct laparoscopic visualization into the rectus sheath bilaterally by the attending surgeon.
Ropivacaine: Ropivacaine is a long-acting local anesthetic. It has been shown to be effective for peripheral nerve, caudal, and lumbar/thoracic epidural blocks and produce less motor blockade than bupivacaine after caudal administration. It will be the local anesthetic used to perform the rectus sheath block for both arms.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
15.83 years
STANDARD_DEVIATION 1.63 • n=24 Participants
|
14.83 years
STANDARD_DEVIATION 4 • n=24 Participants
|
15.33 years
STANDARD_DEVIATION 3.06 • n=48 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=24 Participants
|
20 Participants
n=24 Participants
|
38 Participants
n=48 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=24 Participants
|
4 Participants
n=24 Participants
|
10 Participants
n=48 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
24 Participants
n=24 Participants
|
24 Participants
n=24 Participants
|
48 Participants
n=48 Participants
|
PRIMARY outcome
Timeframe: 5 daysUsing the Wong-Baker FACES Pain Rating Scale (WBFPRS). The WBFPRS is a visual pain rating scale in which the participant looks at pictures of faces depicting levels of pain and chooses the one that most closely resembles their own pain. The scale ranges from 0 "no hurt" to 10 "Hurts Worst."
Outcome measures
| Measure |
Laparoscopic Guided Rectus Sheath Block
n=24 Participants
rectus sheath block under direct laparoscopic visualization by the attending surgeon
Laparoscopic guided rectus sheath block: After removal of the gallbladder, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally) will be administered intra-abdominally under direct laparoscopic visualization into the rectus sheath bilaterally by the attending surgeon.
Ropivacaine: Ropivacaine is a long-acting local anesthetic. It has been shown to be effective for peripheral nerve, caudal, and lumbar/thoracic epidural blocks and produce less motor blockade than bupivacaine after caudal administration. It will be the local anesthetic used to perform the rectus sheath block for both arms.
|
Trans-incisional Rectus Sheath Block
n=24 Participants
rectus sheath block under direct visualization through the umbilical incision by the attending surgeon
Trans-incisional rectus sheath block: After removal of the gallbladder, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon. This will be done after closure of the fascial incision but prior to closure of the skin incision.
Ropivacaine: Ropivacaine is a long-acting local anesthetic. It has been shown to be effective for peripheral nerve, caudal, and lumbar/thoracic epidural blocks and produce less motor blockade than bupivacaine after caudal administration. It will be the local anesthetic used to perform the rectus sheath block for both arms.
|
|---|---|---|
|
Post Operative Pain Rating
|
4.03 score on a scale
Standard Deviation 1.16
|
4.03 score on a scale
Standard Deviation 1.46
|
SECONDARY outcome
Timeframe: 1 dayOperative time is measured as the time between X and Y. Reported in minutes.
Outcome measures
| Measure |
Laparoscopic Guided Rectus Sheath Block
n=24 Participants
rectus sheath block under direct laparoscopic visualization by the attending surgeon
Laparoscopic guided rectus sheath block: After removal of the gallbladder, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally) will be administered intra-abdominally under direct laparoscopic visualization into the rectus sheath bilaterally by the attending surgeon.
Ropivacaine: Ropivacaine is a long-acting local anesthetic. It has been shown to be effective for peripheral nerve, caudal, and lumbar/thoracic epidural blocks and produce less motor blockade than bupivacaine after caudal administration. It will be the local anesthetic used to perform the rectus sheath block for both arms.
|
Trans-incisional Rectus Sheath Block
n=24 Participants
rectus sheath block under direct visualization through the umbilical incision by the attending surgeon
Trans-incisional rectus sheath block: After removal of the gallbladder, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon. This will be done after closure of the fascial incision but prior to closure of the skin incision.
Ropivacaine: Ropivacaine is a long-acting local anesthetic. It has been shown to be effective for peripheral nerve, caudal, and lumbar/thoracic epidural blocks and produce less motor blockade than bupivacaine after caudal administration. It will be the local anesthetic used to perform the rectus sheath block for both arms.
|
|---|---|---|
|
Operative Time
|
60 minutes
Standard Deviation 19
|
62 minutes
Standard Deviation 27
|
SECONDARY outcome
Timeframe: 5 daysAmount of postoperative intravenous/oral opioid and non-opioid medications received by patient. This is being recorded as Morphine milligram equivalents (MME)/kilogram(kg) for days 1-5.
Outcome measures
| Measure |
Laparoscopic Guided Rectus Sheath Block
n=24 Participants
rectus sheath block under direct laparoscopic visualization by the attending surgeon
Laparoscopic guided rectus sheath block: After removal of the gallbladder, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally) will be administered intra-abdominally under direct laparoscopic visualization into the rectus sheath bilaterally by the attending surgeon.
Ropivacaine: Ropivacaine is a long-acting local anesthetic. It has been shown to be effective for peripheral nerve, caudal, and lumbar/thoracic epidural blocks and produce less motor blockade than bupivacaine after caudal administration. It will be the local anesthetic used to perform the rectus sheath block for both arms.
|
Trans-incisional Rectus Sheath Block
n=24 Participants
rectus sheath block under direct visualization through the umbilical incision by the attending surgeon
Trans-incisional rectus sheath block: After removal of the gallbladder, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon. This will be done after closure of the fascial incision but prior to closure of the skin incision.
Ropivacaine: Ropivacaine is a long-acting local anesthetic. It has been shown to be effective for peripheral nerve, caudal, and lumbar/thoracic epidural blocks and produce less motor blockade than bupivacaine after caudal administration. It will be the local anesthetic used to perform the rectus sheath block for both arms.
|
|---|---|---|
|
Use of Post-operative Intravenous/Oral Opioid and Non-opioid
|
056 MME/kg
Standard Deviation .42
|
0.49 MME/kg
Standard Deviation 0.32
|
SECONDARY outcome
Timeframe: 1 dayAmount of time in minutes until the first analgesic is given postoperatively.
Outcome measures
| Measure |
Laparoscopic Guided Rectus Sheath Block
n=24 Participants
rectus sheath block under direct laparoscopic visualization by the attending surgeon
Laparoscopic guided rectus sheath block: After removal of the gallbladder, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally) will be administered intra-abdominally under direct laparoscopic visualization into the rectus sheath bilaterally by the attending surgeon.
Ropivacaine: Ropivacaine is a long-acting local anesthetic. It has been shown to be effective for peripheral nerve, caudal, and lumbar/thoracic epidural blocks and produce less motor blockade than bupivacaine after caudal administration. It will be the local anesthetic used to perform the rectus sheath block for both arms.
|
Trans-incisional Rectus Sheath Block
n=24 Participants
rectus sheath block under direct visualization through the umbilical incision by the attending surgeon
Trans-incisional rectus sheath block: After removal of the gallbladder, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon. This will be done after closure of the fascial incision but prior to closure of the skin incision.
Ropivacaine: Ropivacaine is a long-acting local anesthetic. It has been shown to be effective for peripheral nerve, caudal, and lumbar/thoracic epidural blocks and produce less motor blockade than bupivacaine after caudal administration. It will be the local anesthetic used to perform the rectus sheath block for both arms.
|
|---|---|---|
|
Time to First Rescue Analgesic
|
17.9 minutes
Standard Deviation 16.8
|
14.4 minutes
Standard Deviation 11.3
|
SECONDARY outcome
Timeframe: 5 daysNumber of participants with side effects such as nausea, vomiting, allergic reactions.
Outcome measures
| Measure |
Laparoscopic Guided Rectus Sheath Block
n=24 Participants
rectus sheath block under direct laparoscopic visualization by the attending surgeon
Laparoscopic guided rectus sheath block: After removal of the gallbladder, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally) will be administered intra-abdominally under direct laparoscopic visualization into the rectus sheath bilaterally by the attending surgeon.
Ropivacaine: Ropivacaine is a long-acting local anesthetic. It has been shown to be effective for peripheral nerve, caudal, and lumbar/thoracic epidural blocks and produce less motor blockade than bupivacaine after caudal administration. It will be the local anesthetic used to perform the rectus sheath block for both arms.
|
Trans-incisional Rectus Sheath Block
n=24 Participants
rectus sheath block under direct visualization through the umbilical incision by the attending surgeon
Trans-incisional rectus sheath block: After removal of the gallbladder, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon. This will be done after closure of the fascial incision but prior to closure of the skin incision.
Ropivacaine: Ropivacaine is a long-acting local anesthetic. It has been shown to be effective for peripheral nerve, caudal, and lumbar/thoracic epidural blocks and produce less motor blockade than bupivacaine after caudal administration. It will be the local anesthetic used to perform the rectus sheath block for both arms.
|
|---|---|---|
|
Number of Participants With Side Effects
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 daysNumber of participants with complications such as infection, bleeding, intravascular injection, bowel puncture.
Outcome measures
| Measure |
Laparoscopic Guided Rectus Sheath Block
n=24 Participants
rectus sheath block under direct laparoscopic visualization by the attending surgeon
Laparoscopic guided rectus sheath block: After removal of the gallbladder, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally) will be administered intra-abdominally under direct laparoscopic visualization into the rectus sheath bilaterally by the attending surgeon.
Ropivacaine: Ropivacaine is a long-acting local anesthetic. It has been shown to be effective for peripheral nerve, caudal, and lumbar/thoracic epidural blocks and produce less motor blockade than bupivacaine after caudal administration. It will be the local anesthetic used to perform the rectus sheath block for both arms.
|
Trans-incisional Rectus Sheath Block
n=24 Participants
rectus sheath block under direct visualization through the umbilical incision by the attending surgeon
Trans-incisional rectus sheath block: After removal of the gallbladder, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon. This will be done after closure of the fascial incision but prior to closure of the skin incision.
Ropivacaine: Ropivacaine is a long-acting local anesthetic. It has been shown to be effective for peripheral nerve, caudal, and lumbar/thoracic epidural blocks and produce less motor blockade than bupivacaine after caudal administration. It will be the local anesthetic used to perform the rectus sheath block for both arms.
|
|---|---|---|
|
Number of Participants With Complications
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 daysTotal number of complications such as infection, bleeding, intravascular injection, bowel puncture.
Outcome measures
| Measure |
Laparoscopic Guided Rectus Sheath Block
n=24 Participants
rectus sheath block under direct laparoscopic visualization by the attending surgeon
Laparoscopic guided rectus sheath block: After removal of the gallbladder, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally) will be administered intra-abdominally under direct laparoscopic visualization into the rectus sheath bilaterally by the attending surgeon.
Ropivacaine: Ropivacaine is a long-acting local anesthetic. It has been shown to be effective for peripheral nerve, caudal, and lumbar/thoracic epidural blocks and produce less motor blockade than bupivacaine after caudal administration. It will be the local anesthetic used to perform the rectus sheath block for both arms.
|
Trans-incisional Rectus Sheath Block
n=24 Participants
rectus sheath block under direct visualization through the umbilical incision by the attending surgeon
Trans-incisional rectus sheath block: After removal of the gallbladder, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon. This will be done after closure of the fascial incision but prior to closure of the skin incision.
Ropivacaine: Ropivacaine is a long-acting local anesthetic. It has been shown to be effective for peripheral nerve, caudal, and lumbar/thoracic epidural blocks and produce less motor blockade than bupivacaine after caudal administration. It will be the local anesthetic used to perform the rectus sheath block for both arms.
|
|---|---|---|
|
Total Number of Complications
|
0 complications
|
0 complications
|
Adverse Events
Trans-incisional Rectus Sheath Block
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Laparoscopic Guided Rectus Sheath Block
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Trans-incisional Rectus Sheath Block
n=24 participants at risk
rectus sheath block under direct visualization through the umbilical incision by the attending surgeon
Trans-incisional rectus sheath block: After removal of the gallbladder, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon. This will be done after closure of the fascial incision but prior to closure of the skin incision.
Ropivacaine: Ropivacaine is a long-acting local anesthetic. It has been shown to be effective for peripheral nerve, caudal, and lumbar/thoracic epidural blocks and produce less motor blockade than bupivacaine after caudal administration. It will be the local anesthetic used to perform the rectus sheath block for both arms.
|
Laparoscopic Guided Rectus Sheath Block
n=24 participants at risk
rectus sheath block under direct laparoscopic visualization by the attending surgeon
Laparoscopic guided rectus sheath block: After removal of the gallbladder, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally) will be administered intra-abdominally under direct laparoscopic visualization into the rectus sheath bilaterally by the attending surgeon.
Ropivacaine: Ropivacaine is a long-acting local anesthetic. It has been shown to be effective for peripheral nerve, caudal, and lumbar/thoracic epidural blocks and produce less motor blockade than bupivacaine after caudal administration. It will be the local anesthetic used to perform the rectus sheath block for both arms.
|
|---|---|---|
|
Hepatobiliary disorders
readmission
|
4.2%
1/24 • Number of events 1 • 30 days
|
0.00%
0/24 • 30 days
|
|
Renal and urinary disorders
readmission
|
4.2%
1/24 • Number of events 1 • 30 days
|
0.00%
0/24 • 30 days
|
|
Psychiatric disorders
Attempted suicide
|
0.00%
0/24 • 30 days
|
4.2%
1/24 • Number of events 1 • 30 days
|
Other adverse events
Adverse event data not reported
Additional Information
Nicole Chandler, MD
Johns Hopkins All Children's Hospital
Phone: 7277674170
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place