Treatment for Laparoscopic Cholecystectomy

Phase-Based Estimates
3
Effectiveness
3
Safety
Riley Hospital for Children at IU Health, Indianapolis, IN
Eligibility
< 18
All Sexes
Eligible conditions
Laparoscopic Cholecystectomy

Study Summary

This study is evaluating whether a TAP block is better than local wound infiltration for pain control in children undergoing laparoscopic cholecystectomy.

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Treatment Effectiveness

Study Objectives

This trial is evaluating whether Treatment will improve 2 primary outcomes in patients with Laparoscopic Cholecystectomy. Measurement will happen over the course of From post-anesthesia care unit "(PACU) in" time to first pain medication dose, up to 24 hours.

24 hours post-op
Amount of narcotic pain medication
Hour 24
Time to first request of pain medication

Trial Safety

Trial Design

2 Treatment Groups

Local Wound Infiltration

This trial requires 150 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Local Wound InfiltrationLocal wound infiltration (LWI) will be performed by the operative surgeon using 2.5 mg/kg or 1 mL/kg of 0.2% ropivacaine with maximum of 60 mL divided amongst the four port sites. 40% of the total dose will be given at the umbilicus, and 20% will be given at each of the other 3 ports. The majority of the anesthetic will be administered at the peritoneal level. Laparoscopic/robotic cholecystectomy will be performed with a port at the umbilicus and three smaller ports in a standard fashion in the subxiphoid and right upper quadrant regions. If conversion to open cholecystectomy occurs, the study data will still be collected, but the patient's data will be excluded from analysis.
TAP blocksTAP block group will receive three injections performed by an Anesthesiologist trained in the procedure, prior to initiation of the surgical procedure. Bilateral posterior transversalis fascial plane blocks and a right sided subcostal transverse abdominal plane block will be placed under ultrasound guidance. Normal saline will be used to confirm proper muscle layer placement before instillation of the local anesthesia. All patients will receive 2.5 mg/kg or 1 mL/kg of 0.2% ropivacaine with maximum of 60 mL (divided equally amongst the injection sites).

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 hours post-op
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 24 hours post-op for reporting.

Closest Location

Riley Hospital for Children at IU Health - Indianapolis, IN

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The surgery is an elective laparoscopic or da Vinci cholecystectomy that is being done for any diagnostic reason. show original
The text says that the person must be 8-17 years old at the date of enrollment. show original

Patient Q&A Section

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Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

In order to understand how insurance coverage works for this trial, you will need to contact the study coordinator.

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Get access to this novel treatment for Laparoscopic Cholecystectomy by sharing your contact details with the study coordinator.