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

NCT02494336 | Completed Results DMC

• 1 other identifier: IRB00041111
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Operative Time

  1 day

• Use of Post-operative Intravenous/Oral Opioid and Non-opioid

  5 days

• Time to First Rescue Analgesic

  1 day

• Number of Participants With Side Effects

  5 days

• Number of Participants With Complications

  30 days

Study Arms (2)

Trans-incisional rectus sheath block

ACTIVE COMPARATOR

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

Procedure: Trans-incisional rectus sheath block; Drug: Ropivacaine

Laparoscopic guided rectus sheath block

ACTIVE COMPARATOR

rectus sheath block under direct laparoscopic visualization by the attending surgeon

Procedure: Laparoscopic guided rectus sheath block; Drug: Ropivacaine

Interventions

Trans-incisional rectus sheath block 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.

Trans-incisional rectus sheath block

Laparoscopic guided rectus sheath block 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.

Laparoscopic guided rectus sheath block

Ropivacaine 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.

Also known as: Naropin

Laparoscopic guided rectus sheath block; Trans-incisional rectus sheath block

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• Johns Hopkins All Children's Hospital: lead

Study Sites (1)

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, 33701, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Nicole Chandler, MD
• Organization: Johns Hopkins All Children's Hospital

nicole.chandler@jhmi.edu

7277674170

Study Officials

• Nicole M Chandler, MD

  Johns Hopkins All Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2015
• First Posted: July 10, 2015
• Study Start: June 1, 2015
• Primary Completion: October 1, 2018
• Study Completion: October 31, 2019
• Last Updated: January 22, 2021
• Results First Posted: April 13, 2020

Record last verified: 2021-01

Locations

US (1)