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N/A N=61 Randomized Triple-blind Supportive Care

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

Pain, Postoperative

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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