STALL vs Sole Local Wound Infiltration in Laparoscopic Cholecystectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

850 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-16

Study Completion Date

2027-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cholelithiasis Cholecystitis Gallbladder Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients are analyzed following the intention to treat in three subgroups:

1. Patients treated in "day-care" outpatient surgical unit (DS): TAP+local vs local.
2. Patients treated electively in the inpatient surgery unit (IS): TAP+local vs local.
3. Emergency surgery patients (ES): TAP+local vs local.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The study will be blinded to patients and recovery room personnel, as well as the ward nurses and physicians, but not to operating surgeon(s), anesthesiologist(s), and nurses, treating patients during the surgery.

Study Groups

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Daycare: STALL

Local ropivacaine infiltration + laparoscopically controlled TAP (transversus abdominis plane block). Daycare patients.

Group Type EXPERIMENTAL