Trial Outcomes & Findings for Percutaneous Rectus Sheath Block Versus Intra-operative Rectus Sheath Block for Pediatric Umbilical Hernia Repair (NCT NCT02341144)
NCT ID: NCT02341144
Last Updated: 2023-07-03
Results Overview
Using the Wong-Baker FACES Pain Rating Scale (WBFPRS)- pain scores range from zero (no pain) to ten (worst pain) and the average score was reported
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
61 participants
Primary outcome timeframe
from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours
Results posted on
2023-07-03
Participant Flow
Participant milestones
| Measure |
Pre-op Percutaneous Rectus Sheath Block
ultrasound-guided, percutaneous rectus sheath block by a qualified anesthesiologist
Pre-op percutaneous rectus sheath block: After induction of anesthesia, the attending anesthesiologist will use a portable ultrasound probe to locate the rectus sheath. A 22 gauge needle will be used to inject a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally). The analgesic will be injected percutaneously using ultrasound guidance between the rectus abdominis muscle and the posterior rectus sheath at the lateral border bilaterally.
Ropivacaine
|
Intra-operative Rectus Sheath Block
rectus sheath block under direct visualization by the attending surgeon
Intra-operative rectus sheath block: After the completion of the umbilical hernia repair, after fascial closure, but prior to skin closure, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10c, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon.
Ropivacaine
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
31
|
|
Overall Study
COMPLETED
|
28
|
30
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Percutaneous Rectus Sheath Block Versus Intra-operative Rectus Sheath Block for Pediatric Umbilical Hernia Repair
Baseline characteristics by cohort
| Measure |
Pre-op Percutaneous Rectus Sheath Block
n=28 Participants
ultrasound-guided, percutaneous rectus sheath block by a qualified anesthesiologist
Pre-op percutaneous rectus sheath block: After induction of anesthesia, the attending anesthesiologist will use a portable ultrasound probe to locate the rectus sheath. A 22 gauge needle will be used to inject a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally). The analgesic will be injected percutaneously using ultrasound guidance between the rectus abdominis muscle and the posterior rectus sheath at the lateral border bilaterally.
Ropivacaine
|
Intra-operative Rectus Sheath Block
n=30 Participants
rectus sheath block under direct visualization by the attending surgeon
Intra-operative rectus sheath block: After the completion of the umbilical hernia repair, after fascial closure, but prior to skin closure, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10c, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon.
Ropivacaine
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
6.2 years
n=5 Participants
|
6.2 years
n=7 Participants
|
6.2 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Body mass index (BMI) percentile
|
57 percentile
n=5 Participants
|
77 percentile
n=7 Participants
|
61.2 percentile
n=5 Participants
|
PRIMARY outcome
Timeframe: from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hoursUsing the Wong-Baker FACES Pain Rating Scale (WBFPRS)- pain scores range from zero (no pain) to ten (worst pain) and the average score was reported
Outcome measures
| Measure |
Pre-op Percutaneous Rectus Sheath Block
n=28 Participants
ultrasound-guided, percutaneous rectus sheath block by a qualified anesthesiologist
Pre-op percutaneous rectus sheath block: After induction of anesthesia, the attending anesthesiologist will use a portable ultrasound probe to locate the rectus sheath. A 22 gauge needle will be used to inject a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally). The analgesic will be injected percutaneously using ultrasound guidance between the rectus abdominis muscle and the posterior rectus sheath at the lateral border bilaterally.
Ropivacaine
|
Intra-operative Rectus Sheath Block
n=30 Participants
rectus sheath block under direct visualization by the attending surgeon
Intra-operative rectus sheath block: After the completion of the umbilical hernia repair, after fascial closure, but prior to skin closure, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10c, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon.
Ropivacaine
|
|---|---|---|
|
Post Operative Pain Rating
|
2.6 units on a scale
Interval 0.0 to 6.7
|
3.3 units on a scale
Interval 0.0 to 8.0
|
SECONDARY outcome
Timeframe: from entry in post-anesthesia care unit (PACU) to first narcoticduration until patient received first dose of narcotic in PACU
Outcome measures
| Measure |
Pre-op Percutaneous Rectus Sheath Block
n=28 Participants
ultrasound-guided, percutaneous rectus sheath block by a qualified anesthesiologist
Pre-op percutaneous rectus sheath block: After induction of anesthesia, the attending anesthesiologist will use a portable ultrasound probe to locate the rectus sheath. A 22 gauge needle will be used to inject a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally). The analgesic will be injected percutaneously using ultrasound guidance between the rectus abdominis muscle and the posterior rectus sheath at the lateral border bilaterally.
Ropivacaine
|
Intra-operative Rectus Sheath Block
n=30 Participants
rectus sheath block under direct visualization by the attending surgeon
Intra-operative rectus sheath block: After the completion of the umbilical hernia repair, after fascial closure, but prior to skin closure, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10c, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon.
Ropivacaine
|
|---|---|---|
|
Time to First Narcotic
|
30 minutes
Interval 4.0 to 54.0
|
22 minutes
Interval 2.0 to 112.0
|
SECONDARY outcome
Timeframe: from entry in the post-anesthesia care unit (PACU) until discharge, estimated 1-2 hoursproportion who reported a score of zero throughout their PACU stay using the Wong-Baker (WB) scale with zero being "no pain"
Outcome measures
| Measure |
Pre-op Percutaneous Rectus Sheath Block
n=28 Participants
ultrasound-guided, percutaneous rectus sheath block by a qualified anesthesiologist
Pre-op percutaneous rectus sheath block: After induction of anesthesia, the attending anesthesiologist will use a portable ultrasound probe to locate the rectus sheath. A 22 gauge needle will be used to inject a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally). The analgesic will be injected percutaneously using ultrasound guidance between the rectus abdominis muscle and the posterior rectus sheath at the lateral border bilaterally.
Ropivacaine
|
Intra-operative Rectus Sheath Block
n=30 Participants
rectus sheath block under direct visualization by the attending surgeon
Intra-operative rectus sheath block: After the completion of the umbilical hernia repair, after fascial closure, but prior to skin closure, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10c, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon.
Ropivacaine
|
|---|---|---|
|
Pain Score of Zero
|
5 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hoursmorphine equivalents received in PACU
Outcome measures
| Measure |
Pre-op Percutaneous Rectus Sheath Block
n=28 Participants
ultrasound-guided, percutaneous rectus sheath block by a qualified anesthesiologist
Pre-op percutaneous rectus sheath block: After induction of anesthesia, the attending anesthesiologist will use a portable ultrasound probe to locate the rectus sheath. A 22 gauge needle will be used to inject a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally). The analgesic will be injected percutaneously using ultrasound guidance between the rectus abdominis muscle and the posterior rectus sheath at the lateral border bilaterally.
Ropivacaine
|
Intra-operative Rectus Sheath Block
n=30 Participants
rectus sheath block under direct visualization by the attending surgeon
Intra-operative rectus sheath block: After the completion of the umbilical hernia repair, after fascial closure, but prior to skin closure, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10c, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon.
Ropivacaine
|
|---|---|---|
|
PACU Morphine Equivalents
|
0.04 mg/kg
Interval 0.0 to 0.24
|
0.09 mg/kg
Interval 0.0 to 0.2
|
SECONDARY outcome
Timeframe: from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hoursduration of time spent in the post-anesthesia care unit (PACU) from arrival to discharge
Outcome measures
| Measure |
Pre-op Percutaneous Rectus Sheath Block
n=28 Participants
ultrasound-guided, percutaneous rectus sheath block by a qualified anesthesiologist
Pre-op percutaneous rectus sheath block: After induction of anesthesia, the attending anesthesiologist will use a portable ultrasound probe to locate the rectus sheath. A 22 gauge needle will be used to inject a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally). The analgesic will be injected percutaneously using ultrasound guidance between the rectus abdominis muscle and the posterior rectus sheath at the lateral border bilaterally.
Ropivacaine
|
Intra-operative Rectus Sheath Block
n=30 Participants
rectus sheath block under direct visualization by the attending surgeon
Intra-operative rectus sheath block: After the completion of the umbilical hernia repair, after fascial closure, but prior to skin closure, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10c, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon.
Ropivacaine
|
|---|---|---|
|
PACU Length of Stay (LOS)
|
76 minutes
Interval 56.0 to 159.0
|
80 minutes
Interval 49.0 to 173.0
|
Adverse Events
Pre-op Percutaneous Rectus Sheath Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intra-operative Rectus Sheath Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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