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

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pre-op percutaneous rectus sheath block
Intra-operative rectus sheath block
Ropivacaine
Sponsored by
Johns Hopkins All Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Postoperative

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients aged 3-18 years undergoing elective umbilical hernia repair

Exclusion Criteria:

  • Strangulated or incarcerated umbilical hernia (non-elective)
  • Allergy to bupivacaine/ropivicaine
  • Concurrent surgical procedures
  • Developmental delay or neurologic diagnosis that would interfere with post-operative pain score assessment
  • Chronic pain medication use
  • Chronic pain disorder or complex regional pain syndrome
  • Anesthesiologist classification of III or greater.

Sites / Locations

  • Johns Hopkins All Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Pre-op percutaneous rectus sheath block

Intra-operative rectus sheath block

Arm Description

ultrasound-guided, percutaneous rectus sheath block with ropivacaine by a qualified anesthesiologist

rectus sheath block with ropivacaine under direct visualization by the attending surgeon

Outcomes

Primary Outcome Measures

Post Operative Pain Rating
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

Secondary Outcome Measures

Time to First Narcotic
duration until patient received first dose of narcotic in PACU
Pain Score of Zero
proportion who reported a score of zero throughout their PACU stay using the Wong-Baker (WB) scale with zero being "no pain"
PACU Morphine Equivalents
morphine equivalents received in PACU
PACU Length of Stay (LOS)
duration of time spent in the post-anesthesia care unit (PACU) from arrival to discharge

Full Information

First Posted
December 9, 2014
Last Updated
June 28, 2023
Sponsor
Johns Hopkins All Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02341144
Brief Title
Percutaneous Rectus Sheath Block Versus Intra-operative Rectus Sheath Block for Pediatric Umbilical Hernia Repair
Official Title
Percutaneous Rectus Sheath Block Versus Intra-operative Rectus Sheath Block for Pediatric Umbilical Hernia Repair: A Prospective, Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
March 1, 2016 (Actual)
Study Completion Date
April 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins All Children's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a prospective, double-blinded, randomized controlled study comparing the efficacy of pre-incisional percutaneous rectus sheath block to intra-operative rectus sheath block under direct visualization prior to closure of the incision for providing post-operative analgesia following umbilical hernia repair in children. The current management for reducible umbilical hernias is umbilical hernia repair under general anesthesia as an outpatient procedure. Patients aged 3-18 years old with a diagnosis of umbilical hernia will be screened for study inclusion. Eligible patients and their parents/guardians will be approached and, if agreeable, consented for the study pre-operatively. Patients will be randomized to receive either pre-incisional percutaneous rectus sheath block by the anesthesiologist or intra-operative rectus sheath block under direct visualization prior to closure of the skin incision by the surgeon. The patient, patient guardians, select research team members, and post-anesthesia care unit (PACU) staff will be blinded to the method of analgesic administration.
Detailed Description
Regional anesthesia has been increasingly utilized for providing post-operative analgesia for a number of surgical procedures in children. Rectus sheath block and local anesthetic infiltration of the surgical site are two common modes for providing post-operative analgesia following umbilical hernia repair. Studies comparing the two modes have shown ultrasound-guided rectus sheath block to improve immediate pain scores and reduce use of post-operative analgesia in pediatric patients undergoing umbilical hernia repair. However, these studies have compared pre-incisional ultrasound-guided rectus sheath block to post-operative local anesthetic infiltration as a subcutaneous and/or intradermal injection. The purpose of the investigators' study is to compare the efficacy of pre-incisional percutaneous rectus sheath block to intra-operative rectus sheath block under direct visualization prior to closure of the skin for providing post-operative analgesia following umbilical hernia repair in children. The investigators propose a prospective study where pediatric patients who are undergoing elective umbilical hernia repair will be randomized pre-operatively to receive either pre-incisional, ultrasound guided percutaneous rectus sheath block or intra-operative rectus sheath block under direct visualization prior to closure of the skin. The primary outcome is the post-operative pain rating based on the Wong-Baker Faces Pain Rating Scale (WBFPRS) following umbilical hernia repair. Additional outcomes measured will include: operative times, the use of intravenous/oral opioid and/or non-opioid medication in the post-operative period, duration of analgesia following surgery based on time to first rescue analgesic, intra-operative hemodynamic changes, post-operative hemodynamic changes, incidence of side-effects, and complications. Patients/patient guardians will receive a sheet to document post-operative WBFPRS scores, oral opioid and non-opioid medication administration once discharged to home for a total of 5 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pre-op percutaneous rectus sheath block
Arm Type
Active Comparator
Arm Description
ultrasound-guided, percutaneous rectus sheath block with ropivacaine by a qualified anesthesiologist
Arm Title
Intra-operative rectus sheath block
Arm Type
Active Comparator
Arm Description
rectus sheath block with ropivacaine under direct visualization by the attending surgeon
Intervention Type
Procedure
Intervention Name(s)
Pre-op percutaneous rectus sheath block
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Intra-operative rectus sheath block
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Naropin
Primary Outcome Measure Information:
Title
Post Operative Pain Rating
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
Secondary Outcome Measure Information:
Title
Time to First Narcotic
Description
duration until patient received first dose of narcotic in PACU
Time Frame
from entry in post-anesthesia care unit (PACU) to first narcotic
Title
Pain Score of Zero
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
Title
PACU Morphine Equivalents
Description
morphine equivalents received in PACU
Time Frame
from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours
Title
PACU Length of Stay (LOS)
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged 3-18 years undergoing elective umbilical hernia repair Exclusion Criteria: Strangulated or incarcerated umbilical hernia (non-elective) Allergy to bupivacaine/ropivicaine Concurrent surgical procedures Developmental delay or neurologic diagnosis that would interfere with post-operative pain score assessment Chronic pain medication use Chronic pain disorder or complex regional pain syndrome Anesthesiologist classification of III or greater.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole M Chandler, MD
Organizational Affiliation
Johns Hopkins All Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins All Children's Hospital
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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