Clinical trial NCT02494336: Trans-incisional vs Laparoscopic Guided Rectus Sheath Block for Pediatric Single Incision Laparoscopic Cholecystectomy
Official title: Trans-incisional Rectus Sheath Block Versus Laparoscopic Guided Rectus Sheath Block for Pediatric Single Incision Laparoscopic Cholecystectomy: A Prospective, Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: Johns Hopkins All Children's Hospital
Sponsor class: OTHER
First posted: 2015-07-10
Enrollment: 48
Sex: ALL
Minimum age (years): 10
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Post Operative Pain Rating
timeFrame: 5 days
Secondary outcomes:
measure: Operative Time
timeFrame: 1 day
measure: Use of Post-operative Intravenous/Oral Opioid and Non-opioid
timeFrame: 5 days
measure: Time to First Rescue Analgesic
timeFrame: 1 day
measure: Number of Participants With Side Effects
timeFrame: 5 days
measure: Number of Participants With Complications
timeFrame: 30 days
measure: Total Number of Complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Saint Petersburg
country: United States
facility: Johns Hopkins All Children's Hospital
state: Florida
Study officials:
affiliation: Johns Hopkins All Children's Hospital
name: Nicole M Chandler, MD
role: PRINCIPAL_INVESTIGATOR
References: