N/A N=48 Randomized Triple-blind Supportive Care

Trans-incisional vs Laparoscopic Guided Rectus Sheath Block for Pediatric Single Incision Laparoscopic Cholecystectomy

Pain, Postoperative

Bottom Line

View on ClinicalTrials.gov: NCT02494336 ↗

Enrolled (actual)

Serious AEs

6.3%

Results posted

Apr 2020

Primary outcome: Primary: Post Operative Pain Rating — 4.03; 4.03 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Trans-incisional rectus sheath block (Procedure); Laparoscopic guided rectus sheath block (Procedure); Ropivacaine (Drug)
Age: Pediatric, Adult · 10+ yrs
Sex: All
Sponsor: Johns Hopkins All Children's Hospital
Primary completion: Oct 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Post Operative Pain Rating	4.03; 4.03	—
SECONDARY Operative Time	62; 60	—
SECONDARY Use of Post-operative Intravenous/Oral Opioid and Non-opioid	0.49; 056	—
SECONDARY Time to First Rescue Analgesic	14.4; 17.9	—
SECONDARY Number of Participants With Side Effects	0; 0	—
SECONDARY Number of Participants With Complications	0; 0	—
SECONDARY Total Number of Complications	0; 0	—

Summary

This is a prospective, double-blinded, randomized controlled study comparing the efficacy of trans-incisional rectus sheath block to laparoscopic guided rectus sheath block for pediatric single-incision laparoscopic cholecystectomy (SILC). umbilical hernia repair in children. Patients aged 10-21 years old undergoing SILC for cholelithiasis, cholecystitis, or biliary dyskinesia 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 trans-incisional rectus sheath block or intra-operative rectus sheath block under direct laparoscopic visualization. Both will be done by the attending pediatric 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 10-21 years old undergoing single-incision laparoscopic cholecystectomy

Exclusion Criteria

Patients with choledocolithiasis, gallstone pancreatitis, or sickle cell disease
Allergy to bupivacaine
Concurrent surgical procedure
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

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Data sourced from ClinicalTrials.gov (NCT02494336). 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.