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Efficacy of Transversus Abdominis Plane Block for Laparoscopic Cholecystectomy

NCT02712151 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2024-07-08

No results posted yet for this study

Summary

Laparoscopic cholecystectomy is associated with considerable postoperative pain and surgeon-administered local anesthetic infiltration is the standard practice for achieving post-operative analgesia. However, recent studies have shown that pediatric patients continue to experience significant pain during the first 24 hours.

The investigators plan to conduct a prospective, double-blinded, randomized study where patients will be designated into either a test group receiving an ultrasound-guided transversus abdominis plane (TAP) and rectus sheath (RS) blocks with ropivacaine and peri-portal sterile saline or the control group that will receive ultrasound-guided TAP block with sterile saline and peri-portal infiltration of ropivacaine. The anesthesia team and surgical team will both be blinded as well as the research personal in the postoperative period. Patients age 5-17 and American Society of Anesthesiology status I and II undergoing laparoscopic cholecystectomy will be included.

The study hypothesis is that ultrasound-guided peripheral nerve blocks, specifically single shot transversus abdominis plane and rectus sheath blocks, are superior to local wound infiltration during laparoscopic cholecystectomy for decreasing postoperative pain and pain related behavior and facilitating functional recovery.

Conditions

  • Pain, Postoperative

Interventions

PROCEDURE

Abdominal Wall Block

bilateral TAP and RS blocks.

PROCEDURE

Surgical infiltration

distributed between the 4 laparoscopic port sites.

DRUG

Sterile saline

Placebo injection

DRUG

Ropivacaine 0.2%

Ropivacaine 0.2% 1.0 ml/kg total in divided doses for bilateral TAP and RS blocks.

DEVICE

Ultrasound

For nerve localization

DRUG

Ropivacaine 0.5%

Ropivacaine 0.5% 0.4 ml/kg total in divided doses distributed between the 4 laparoscopic port sites

Sponsors & Collaborators

Principal Investigators

  • Karen Boretsky, MD · Boston Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2026-11-30
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02712151 on ClinicalTrials.gov