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

NCT ID: NCT02494336

Last Updated: 2021-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2019-10-31

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.

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Trans-incisional rectus sheath block

rectus sheath block under direct visualization through the umbilical incision by the attending surgeon

Group Type: ACTIVE_COMPARATOR

Trans-incisional rectus sheath block

Intervention Type: PROCEDURE

After removal of the gallbladder, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon. This will be done after closure of the fascial incision but prior to closure of the skin incision.

Ropivacaine

Intervention Type: DRUG

Ropivacaine is a long-acting local anesthetic. It has been shown to be effective for peripheral nerve, caudal, and lumbar/thoracic epidural blocks and produce less motor blockade than bupivacaine after caudal administration. It will be the local anesthetic used to perform the rectus sheath block for both arms.

Laparoscopic guided rectus sheath block

rectus sheath block under direct laparoscopic visualization by the attending surgeon

Group Type: ACTIVE_COMPARATOR

Laparoscopic guided rectus sheath block

Intervention Type: PROCEDURE

After removal of the gallbladder, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally) will be administered intra-abdominally under direct laparoscopic visualization into the rectus sheath bilaterally by the attending surgeon.

Ropivacaine

Intervention Type: DRUG

Ropivacaine is a long-acting local anesthetic. It has been shown to be effective for peripheral nerve, caudal, and lumbar/thoracic epidural blocks and produce less motor blockade than bupivacaine after caudal administration. It will be the local anesthetic used to perform the rectus sheath block for both arms.

Interventions

Trans-incisional rectus sheath block

After removal of the gallbladder, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon. This will be done after closure of the fascial incision but prior to closure of the skin incision.

Intervention Type: PROCEDURE

Laparoscopic guided rectus sheath block

After removal of the gallbladder, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally) will be administered intra-abdominally under direct laparoscopic visualization into the rectus sheath bilaterally by the attending surgeon.

Intervention Type: PROCEDURE

Ropivacaine

Ropivacaine is a long-acting local anesthetic. It has been shown to be effective for peripheral nerve, caudal, and lumbar/thoracic epidural blocks and produce less motor blockade than bupivacaine after caudal administration. It will be the local anesthetic used to perform the rectus sheath block for both arms.

Intervention Type: DRUG

Other Intervention Names

Naropin

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins All Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicole M Chandler, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins All Children's Hospital

Locations

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00041111

Identifier Type: -

Identifier Source: org_study_id