RecruitingNot ApplicableNCT06123117

STALL vs Sole Local Wound Infiltration in Laparoscopic Cholecystectomy

Single Transversus Abdominis Laparoscopy-guided Plane Block Combined With Local Trocar Site Ropivacaine Infiltration (STALL) vs Sole Local Wound Infiltration in LCC (Laparoscopic CholeCystectomy) - Double-blinded Randomized Controlled Trial.


Sponsor

Helsinki University Central Hospital

Enrollment

850 participants

Start Date

Jan 16, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This trial is a prospective randomized superiority trial comparing sole ropivacaine based local trocar site infiltration to local infiltration combined with laparoscopic ropivacaine TAP block (STALL) in LCC. There are only a few randomized trials comparing sole local anesthesia to additional laparoscopic TAP block in laparoscopic cholecystectomy and they have yet failed to show evidence in favor of TAP block. We hypothesize STALL (Single Transversus Abdominis Laparoscopy-guided plane block combined with Local trocar site ropivacaine infiltration) is superior to local port site infiltration, provided that the sample size is sufficiently big. The aim of this randomized study is to compare the efficacy of sole local anesthesia of trocar sites to STALL in LCC.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two methods of managing pain after laparoscopic gallbladder removal surgery (called laparoscopic cholecystectomy). One method injects local anesthetic into the abdominal wall muscles (STALL block), and the other only injects it at the wound site. The goal is to find the most effective way to reduce pain after this common surgery. **You may be eligible if...** - You are 18 years old or older - You are scheduled for either planned or emergency laparoscopic gallbladder removal surgery - You are able to give informed consent **You may NOT be eligible if...** - You are under 18 years old - You regularly use opioids or pain-modifying medications - You are pregnant - You have a known allergy to local anesthetics - You have a serious blood clotting disorder - You are unable to provide consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREsingle transversus abdominis laparoscopy-guided plane block

please see arm/group descriptions

PROCEDURElocal trocar site ropivacaine infiltration

please see arm/group descriptions


Locations(1)

Jorvi hospital / HUS

Espoo, Uusimaa, Finland

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NCT06123117


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