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Percutaneous Rectus Sheath Block Versus Intra-operative Rectus Sheath Block for Pediatric Umbilical Hernia Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02341144
Recruitment Status : Completed
First Posted : January 19, 2015
Results First Posted : May 16, 2017
Last Update Posted : July 9, 2020
Sponsor:
Information provided by (Responsible Party):
Nicole Chandler, Johns Hopkins All Children's Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition Pain, Postoperative
Interventions Procedure: Pre-op percutaneous rectus sheath block
Procedure: Intra-operative rectus sheath block
Drug: Ropivacaine
Enrollment 61
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pre-op Percutaneous Rectus Sheath Block Intra-operative Rectus Sheath Block
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 30 31
Completed 28 30
Not Completed 2 1
Arm/Group Title Pre-op Percutaneous Rectus Sheath Block Intra-operative Rectus Sheath Block Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 28 30 58
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 28 participants 30 participants 58 participants
6.2
(3.2 to 15.4)
6.2
(4.1 to 17.2)
6.2
(3.2 to 17.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 30 participants 58 participants
Female
16
  57.1%
17
  56.7%
33
  56.9%
Male
12
  42.9%
13
  43.3%
25
  43.1%
Body mass index (BMI) percentile   [1] 
Median (Full Range)
Unit of measure:  Percentile
Number Analyzed 28 participants 30 participants 58 participants
57
(3 to 99)
77
(5 to 98)
61.2
(3 to 99)
[1]
Measure Description: body mass index (BMI) percentile: weight (kg) divided by height (m) relative to other children in the US of the same age and sex
1.Primary Outcome
Title Post Operative Pain Rating
Hide Description 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
Time Frame from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pre-op Percutaneous Rectus Sheath Block Intra-operative Rectus Sheath Block
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 28 30
Mean (Full Range)
Unit of Measure: units on a scale
2.6
(0 to 6.7)
3.3
(0 to 8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pre-op Percutaneous Rectus Sheath Block, Intra-operative Rectus Sheath Block
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Time to First Narcotic
Hide Description duration until patient received first dose of narcotic in PACU
Time Frame from entry in post-anesthesia care unit (PACU) to first narcotic
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pre-op Percutaneous Rectus Sheath Block Intra-operative Rectus Sheath Block
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 28 30
Median (Full Range)
Unit of Measure: minutes
30
(4 to 54)
22
(2 to 112)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pre-op Percutaneous Rectus Sheath Block, Intra-operative Rectus Sheath Block
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.08
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title Pain Score of Zero
Hide Description proportion who reported a score of zero throughout their PACU stay using the Wong-Baker (WB) scale with zero being "no pain"
Time Frame from entry in the post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pre-op Percutaneous Rectus Sheath Block Intra-operative Rectus Sheath Block
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 28 30
Measure Type: Count of Participants
Unit of Measure: Participants
5
  17.9%
3
  10.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pre-op Percutaneous Rectus Sheath Block, Intra-operative Rectus Sheath Block
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.39
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
4.Secondary Outcome
Title PACU Morphine Equivalents
Hide Description morphine equivalents received in PACU
Time Frame from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pre-op Percutaneous Rectus Sheath Block Intra-operative Rectus Sheath Block
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 28 30
Median (Full Range)
Unit of Measure: mg/kg
0.04
(0 to 0.24)
0.09
(0 to 0.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pre-op Percutaneous Rectus Sheath Block, Intra-operative Rectus Sheath Block
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title PACU Length of Stay (LOS)
Hide Description duration of time spent in the post-anesthesia care unit (PACU) from arrival to discharge
Time Frame from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pre-op Percutaneous Rectus Sheath Block Intra-operative Rectus Sheath Block
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 28 30
Median (Full Range)
Unit of Measure: minutes
76
(56 to 159)
80
(49 to 173)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pre-op Percutaneous Rectus Sheath Block, Intra-operative Rectus Sheath Block
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.44
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame 30 days postoperatively
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pre-op Percutaneous Rectus Sheath Block Intra-operative Rectus Sheath Block
Hide Arm/Group Description

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

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

All-Cause Mortality
Pre-op Percutaneous Rectus Sheath Block Intra-operative Rectus Sheath Block
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/30 (0.00%) 
Hide Serious Adverse Events
Pre-op Percutaneous Rectus Sheath Block Intra-operative Rectus Sheath Block
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/30 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pre-op Percutaneous Rectus Sheath Block Intra-operative Rectus Sheath Block
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/30 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Nicole Chandler
Organization: Johns Hopkins All Children's Hospital
Phone: 7277674170 ext 727
EMail: nicole.chandler@jhmi.edu
Layout table for additonal information
Responsible Party: Nicole Chandler, Johns Hopkins All Children's Hospital
ClinicalTrials.gov Identifier: NCT02341144    
Other Study ID Numbers: IRB00041103
First Submitted: December 9, 2014
First Posted: January 19, 2015
Results First Submitted: March 2, 2017
Results First Posted: May 16, 2017
Last Update Posted: July 9, 2020