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

Not Applicable

Completed

Conditions: Pain, Postoperative

Interventions: Procedure: Trans-incisional rectus sheath block
Procedure: Laparoscopic guided rectus sheath block
Drug: Ropivacaine

Registration Number: NCT02494336

Lead Sponsor: Johns Hopkins All Children's Hospital

Brief 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.

Detailed Description: Regional anesthesia has been increasingly utilized for providing post-operative analgesia for a number of surgical procedures in children. Rectus sheath block and local anesthetic infiltration of the surgical site are two common modes for providing post-operative analgesia. Studies comparing the two modes have shown ultrasound-guided rectus sheath block to improve immediate pain scores and reduce use of post-operative analgesia in pediatric patients undergoing umbilical hernia repair. However, these studies have compared pre-incisional ultrasound-guided rectus sheath block to post-operative local anesthetic infiltration as a subcutaneous and/or intradermal injection. Also, to our knowledge, there are no studies evaluating the use or efficacy of laparoscopic guided rectus sheath block for pediatric single-incision laparoscopic surgery. Single-incision surgery involves performing abdominal operations though a single, small incision, usually located at the umbilicus.

The purpose of this study is to compare the efficacy of trans-incisional rectus sheath block to intra-operative infiltration of the rectus sheath under direct laparoscopic visualization via an intra-abdominal approach for providing post-operative analgesia following single-incision laparoscopic cholecystectomy (SILC) in children.

The investigators propose a prospective study where pediatric patients who are undergoing single-incision laparoscopic cholecystectomy will be randomized pre-operatively to receive either a trans-incisional rectus sheath block after facial closure but prior to skin closure or intra-operative infiltration of the rectus sheath under direct laparoscopic visualization after cholecystectomy. The primary outcome is the post-operative pain rating based on the Wong-Baker Faces Pain Rating Scale (WBFPRS) following SILC. Additional outcomes measured will include: operative times, the use of intravenous/oral opioid and/or non-opioid medication in the post-operative period, duration of analgesia following surgery based on time to first rescue analgesic, intra-operative hemodynamic changes, post-operative hemodynamic changes, incidence of side-effects, and complications. Patients/patient guardians will receive a sheet to document post-operative WBFPRS scores, oral opioid and non-opioid medication administration once discharged to home for a total of 5 days.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 48

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trans-incisional rectus sheath block	Trans-incisional rectus sheath block	rectus sheath block under direct visualization through the umbilical incision by the attending surgeon
Laparoscopic guided rectus sheath block	Laparoscopic guided rectus sheath block	rectus sheath block under direct laparoscopic visualization by the attending surgeon
Trans-incisional rectus sheath block	Ropivacaine	rectus sheath block under direct visualization through the umbilical incision by the attending surgeon
Laparoscopic guided rectus sheath block	Ropivacaine	rectus sheath block under direct laparoscopic visualization by the attending surgeon

Primary Outcome Measures

Name	Time	Method
Post Operative Pain Rating	5 days	Using the Wong-Baker FACES Pain Rating Scale (WBFPRS). The WBFPRS is a visual pain rating scale in which the participant looks at pictures of faces depicting levels of pain and chooses the one that most closely resembles their own pain. The scale ranges from 0 "no hurt" to 10 "Hurts Worst."

Secondary Outcome Measures

Name	Time	Method
Operative Time	1 day	Operative time is measured as the time between X and Y. Reported in minutes.
Use of Post-operative Intravenous/Oral Opioid and Non-opioid	5 days	Amount of postoperative intravenous/oral opioid and non-opioid medications received by patient. This is being recorded as Morphine milligram equivalents (MME)/kilogram(kg) for days 1-5.
Time to First Rescue Analgesic	1 day	Amount of time in minutes until the first analgesic is given postoperatively.
Number of Participants With Side Effects	5 days	Number of participants with side effects such as nausea, vomiting, allergic reactions.
Number of Participants With Complications	30 days	Number of participants with complications such as infection, bleeding, intravascular injection, bowel puncture.
Total Number of Complications	30 days	Total number of complications such as infection, bleeding, intravascular injection, bowel puncture.