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

Trans-incisional Rectus Sheath Block Versus Laparoscopic Guided Rectus Sheath Block for Pediatric Single Incision Laparoscopic Cholecystectomy: A Prospective, Randomized Study

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Procedure: Trans-incisional rectus sheath block; Drug: Ropivacaine; Procedure: Laparoscopic guided rectus sheath block

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Saint Petersburg, Florida, United States, 33701
      • Johns Hopkins All Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 21 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Trans-incisional rectus sheath block; rectus sheath block under direct visualization through the umbilical incision by the attending surgeon	Procedure: 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.; Drug: 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.; Other Names: Naropin
Active Comparator: Laparoscopic guided rectus sheath block; rectus sheath block under direct laparoscopic visualization by the attending surgeon	Drug: 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.; Other Names: Naropin; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post Operative Pain Rating	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."	5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative Time	Operative time is measured as the time between X and Y. Reported in minutes.	1 day
Use of Post-operative Intravenous/Oral Opioid and Non-opioid	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.	5 days
Time to First Rescue Analgesic	Amount of time in minutes until the first analgesic is given postoperatively.	1 day
Number of Participants With Side Effects	Number of participants with side effects such as nausea, vomiting, allergic reactions.	5 days
Number of Participants With Complications	Number of participants with complications such as infection, bleeding, intravascular injection, bowel puncture.	30 days
Total Number of Complications	Total number of complications such as infection, bleeding, intravascular injection, bowel puncture.	30 days

Collaborators and Investigators

• Sponsor: Johns Hopkins All Children's Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): October 31, 2019

Study Registration Dates

• First Submitted: July 8, 2015
• First Submitted That Met QC Criteria: July 8, 2015
• First Posted (Estimate): July 10, 2015

Study Record Updates

• Last Update Posted (Actual): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 4, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: IRB00041111