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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Ropivacaine; Procedure: Pre-op percutaneous rectus sheath block; Procedure: Intra-operative rectus sheath block

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.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Saint Petersburg, Florida, United States, 33701
      • Johns Hopkins All Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pre-op percutaneous rectus sheath block; ultrasound-guided, percutaneous rectus sheath block with ropivacaine by a qualified anesthesiologist	Drug: Ropivacaine; Other Names: Naropin; Procedure: 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.
Active Comparator: Intra-operative rectus sheath block; rectus sheath block with ropivacaine under direct visualization by the attending surgeon	Drug: Ropivacaine; Other Names: Naropin; Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to First Narcotic	duration until patient received first dose of narcotic in PACU	from entry in post-anesthesia care unit (PACU) to first narcotic
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"	from entry in the post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours
PACU Morphine Equivalents	morphine equivalents received in PACU	from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours
PACU Length of Stay (LOS)	duration of time spent in the post-anesthesia care unit (PACU) from arrival to discharge	from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours

Collaborators and Investigators

• Sponsor: Johns Hopkins All Children's Hospital
• Investigators: Principal Investigator: Nicole M Chandler, MD, Johns Hopkins All Children's Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: December 9, 2014
• First Submitted That Met QC Criteria: January 16, 2015
• First Posted (Estimated): January 19, 2015

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 28, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Infant, Newborn, Diseases; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral; Pain, Postoperative; Hernia, Umbilical; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: IRB00041103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO