N/A
N=61
Percutaneous Rectus Sheath Block Versus Intra-operative Rectus Sheath Block for Pediatric Umbilical Hernia Repair
Pain, Postoperative
Bottom Line
View on ClinicalTrials.gov: NCT02341144 ↗Enrolled (actual)
61
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Post Operative Pain Rating — 2.6; 3.3 units on a scale — p=0.11
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pre-op percutaneous rectus sheath block (Procedure); Intra-operative rectus sheath block (Procedure); Ropivacaine (Drug)
- Age
- Pediatric, Adult · 3+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins All Children's Hospital
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post Operative Pain Rating |
2.6; 3.3 | 0.11 |
| SECONDARY Time to First Narcotic |
30; 22 | 0.08 |
| SECONDARY Pain Score of Zero |
5; 3 | 0.39 |
| SECONDARY PACU Morphine Equivalents |
0.04; 0.09 | 0.11 |
| SECONDARY PACU Length of Stay (LOS) |
76; 80 | 0.44 |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02341144). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.