Clinical trial

Percutaneous Rectus Sheath Block Versus Intra-operative Rectus Sheath Block for Pediatric Umbilical Hernia Repair: A Prospective, Randomized Study

Name

IRB00041103

Description

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.

Trial arms

Trial start

2014-12-01

Estimated PCD

2016-03-01

Trial end

2016-04-01

Status

Completed

Treatment

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.

Arms:

Pre-op percutaneous rectus sheath block

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.

Arms:

Intra-operative rectus sheath block

Ropivacaine

Arms:

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

Other names:

Naropin

Size

Primary endpoint

Post Operative Pain Rating

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

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 61, 'type': 'ACTUAL'}}

Updated at

2023-07-03

1 organization

1 product

2 indications

Organization

Johns Hopkins All Children's Hospital

Product

Ropivacaine

Indication

Pain

Indication

Postoperative