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Ropivacaine

Anesthetics

Anesthetics, Local

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

Local ropivacaine infiltration only. Daycare patients.

Local ropivacaine infiltration + laparoscopically controlled TAP. In-patient surgery.

Local ropivacaine infiltration only. In-patient surgery.

Local ropivacaine infiltration + laparoscopically controlled TAP. Emergency patients.

Local ropivacaine infiltration only. Emergency patients.

single transversus abdominis laparoscopy-guided plane block

local trocar site ropivacaine infiltration

Roman Kornõšev, MD

Alexey Schramko, MD, PhD, Doc

Roman Kornõšev

Alexey Schramko, PhD, Doc

Henna Sammalkorpi, MD, PhD

Hanna Lampela, MD, PhD

Jukka Harju, MD, PhD, Doc

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.

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.

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.

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.

min, (= "patient ready to be discharged" timestamp OR "patient ready for transfer")

TAP + port site infiltration complications (as per trial plan) + other complications according to Clavien-Dindo classification

using questionnaires, multiple timepoints: recovery stay, hospital stay, discharge, feedback after 7 days

APS (acute pain service) contact, admission of DS subgroup patient to the ward due to pain, failure to discharge

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
STALL vs Sole Local Wound Infiltration in Laparoscopic Cholecystectomy	NCT06123117	Cholelithiasis Cholecystitis Gallbladder Can...	single transver... local trocar si...	18 Years -	Helsinki University Central Hospital
STALL vs Sole Local Wound Infiltration in Laparoscopic Cholecystectomy	NCT06123117	Cholelithiasis Cholecystitis Gallbladder Can...	single transver... local trocar si...	18 Years -	Helsinki University Central Hospital

Spots Global Cancer Trial Database for local trocar site ropivacaine infiltration