NCT03022279

Nerve Blocks vs Local Injections for Post-op Pain Prevention in Laparoscopic Cholecystectomy in Children

Transversus Abdominis Plane Block vs. Local Wound Infiltration for Elective Laparoscopic Cholecystectomy in Children and Adolescents: A Prospective Randomized-Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Brian Wallace Gray · Academic / Other
• Sex: All
• Age: 8 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to compare transversus abdominis plane (TAP) blocks to local wound infiltration (LWI) in terms of postoperative pain control in pediatric patients undergoing elective laparoscopic cholecystectomy. Our hypothesis is that TAP blocks will be superior to LWI for postoperative pain control resulting in decreased use of opioid / narcotic pain medication and decreased pain scored in the immediate 24-hour postoperative period. The rationale is that determining the effect of analgesia in this pediatric population is important to optimize clinical care.

Detailed description

In this study, patients ages 8 through 17 years scheduled for elective laparoscopic cholecystectomy will be invited to participate. Those having da Vinci cholecystectomy procedures will also be eligible. The da Vinci System is a minimally invasive option utilizing robotic technology. Once randomized, the patient will undergo either ultrasound guided bilateral TAP blocks or LWI at the beginning of the surgical procedure. Prospective data regarding pain scores, use of opioid medication, and nausea and vomiting episodes will be collected for both groups. Due to the nature of the study, it will not be possible to blind the investigators to the randomly selected method of injecting local anesthesia; however the personnel involved in the post-anesthetic and post-operative assessment will be blinded to the intervention, as well as the subjects themselves.

Conditions

• Laparoscopic Cholecystectomy

Interventions

Type	Name	Description
PROCEDURE	TAP Blocks	ultrasound guided transversus abdominis plane block utilizing 2.5 mg/kg or 1 mL/kg of 0.2% ropivacaine
PROCEDURE	local wound infiltration	local anesthesia provided at the surgical site utilizing 2.5 mg/kg or 1 mL/kg of 0.2% ropivacaine

Timeline

• Start date: 2017-01-06
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2017-01-16
• Last updated: 2023-03-03

Locations

1 site across 1 country: United States