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

NCT02341144 | Completed Results DMC

• 1 other identifier: IRB00041103
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• 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

  from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours

Secondary Outcomes (4)

• Time to First Narcotic

  from entry in post-anesthesia care unit (PACU) to first narcotic

• Pain Score of Zero

  from entry in the post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours

• PACU Morphine Equivalents

  from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours

• PACU Length of Stay (LOS)

  from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours

Study Arms (2)

Pre-op percutaneous rectus sheath block

ACTIVE COMPARATOR

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

Procedure: Pre-op percutaneous rectus sheath block; Drug: Ropivacaine

Intra-operative rectus sheath block

ACTIVE COMPARATOR

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

Procedure: Intra-operative rectus sheath block; Drug: Ropivacaine

Interventions

Pre-op percutaneous rectus sheath block PROCEDURE

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.

Pre-op percutaneous rectus sheath block

Intra-operative rectus sheath block PROCEDURE

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.

Intra-operative rectus sheath block

Ropivacaine DRUG

Also known as: Naropin

Intra-operative rectus sheath block; Pre-op percutaneous rectus sheath block

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins All Children's Hospital: lead

Study Sites (1)

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, 33701, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Nicole Chandler
• Organization: Johns Hopkins All Children's Hospital

nicole.chandler@jhmi.edu

7277674170

Study Officials

• Nicole M Chandler, MD

  Johns Hopkins All Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2014
• First Posted: January 19, 2015
• Study Start: December 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: April 1, 2016
• Last Updated: July 3, 2023
• Results First Posted: May 16, 2017

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)