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

Not Applicable

Completed

Conditions: Pain, Postoperative

Interventions: Procedure: Pre-op percutaneous rectus sheath block
Procedure: Intra-operative rectus sheath block
Drug: Ropivacaine

Registration Number: NCT02341144

Lead Sponsor: Johns Hopkins All Children's Hospital

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 61

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pre-op percutaneous rectus sheath block	Pre-op percutaneous rectus sheath block	ultrasound-guided, percutaneous rectus sheath block with ropivacaine by a qualified anesthesiologist
Pre-op percutaneous rectus sheath block	Ropivacaine	ultrasound-guided, percutaneous rectus sheath block with ropivacaine by a qualified anesthesiologist
Intra-operative rectus sheath block	Intra-operative rectus sheath block	rectus sheath block with ropivacaine under direct visualization by the attending surgeon
Intra-operative rectus sheath block	Ropivacaine	rectus sheath block with ropivacaine under direct visualization by the attending surgeon

Primary Outcome Measures

Name	Time	Method
Post Operative Pain Rating	from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours	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

Name	Time	Method
Pain Score of Zero	from entry in the post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours	proportion who reported a score of zero throughout their PACU stay using the Wong-Baker (WB) scale with zero being "no pain"
Time to First Narcotic	from entry in post-anesthesia care unit (PACU) to first narcotic	duration until patient received first dose of narcotic in PACU
PACU Morphine Equivalents	from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours	morphine equivalents received in PACU
PACU Length of Stay (LOS)	from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours	duration of time spent in the post-anesthesia care unit (PACU) from arrival to discharge