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

Completed · Not applicable

Conditions studied: Pain, Postoperative

In brief

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.

Key facts

Study ID

NCT02494336

Run by

Johns Hopkins All Children's Hospital

People needed

48

Starts

2015-06-01

Expected to finish

2019-10-31

Last updated by the study team

2021-01-22

Who can join

Age: 10 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients aged 10-21 years old undergoing single-incision laparoscopic cholecystectomy

You may not qualify if…

• 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

Where it is running

• Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States

Full record on ClinicalTrials.gov

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