Clinical trial NCT02341144: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: Johns Hopkins All Children's Hospital
Sponsor class: OTHER
First posted: 2015-01-19
Enrollment: 61
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Post Operative Pain Rating
timeFrame: from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours
Secondary outcomes:
measure: Time to First Narcotic
timeFrame: from entry in post-anesthesia care unit (PACU) to first narcotic
measure: Pain Score of Zero
timeFrame: from entry in the post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours
measure: PACU Morphine Equivalents
timeFrame: from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours
measure: PACU Length of Stay (LOS)
timeFrame: from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours
Other outcomes:
Locations:
city: Saint Petersburg
country: United States
facility: Johns Hopkins All Children's Hospital
state: Florida
Study officials:
affiliation: Johns Hopkins All Children's Hospital
name: Nicole M Chandler, MD
role: PRINCIPAL_INVESTIGATOR
References: