STALL vs Sole Local Wound Infiltration in Laparoscopic Cholecystectomy

Not Applicable

Recruiting

• Conditions: Cholelithiasis; Cholecystitis; Gallbladder Cancer

• Registration Number: NCT06123117
• Lead Sponsor: Helsinki University Central Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-05
• Study First Submitted QC: 2023-11-05
• Study First Posted: 2023-11-08
• Study Start: 2024-01-16
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13
• Primary Completion: 2025-07
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 850

Inclusion Criteria

• All patients scheduled for elective or emergency LCC, aged over 18 and able to give an informed consent.

Exclusion Criteria

• Age under 18 years, chronic daily opioid and/or pain tolerance / pain threshold -modifying medication use (abuse), pregnancy, known allergy to local anesthetics, diagnosed severe coagulopathy and incapability to give informed consent for whatever reason.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
cumulative opioid consumption during the stay at the recovery	duration of stay at the recovery (estimated 1-4 hours)	all groups; mg, morphine equivalent

Secondary Outcome Measures

Name	Time	Method
cumulative opioid consumption (emergency and inpatient surgery)	while admitted; est. 2 days	mg, morphine equivalent
maximum NRS score during the day of surgery, after discharge (daycare / outpatient)	30 min after surgery, every 60 min afterwards; 2 days	NRS (Numerical Rating Scale): 0-10

Trial Locations

Locations (1)

Jorvi hospital / HUS; 🇫🇮 Espoo, Uusimaa, Finland