Overview

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

Status:
Completed
Trial end date:
2019-10-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Johns Hopkins All Children's Hospital
Treatments:
Ropivacaine
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