NCT06123117

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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 850 (estimated)
• Sponsor: Helsinki University Central Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cholelithiasis
• Cholecystitis
• Gallbladder Cancer

Interventions

Type	Name	Description
PROCEDURE	single transversus abdominis laparoscopy-guided plane block	please see arm/group descriptions
PROCEDURE	local trocar site ropivacaine infiltration	please see arm/group descriptions

Timeline

• Start date: 2024-01-16
• Primary completion: 2025-12-01
• Completion: 2027-10-01
• First posted: 2023-11-08
• Last updated: 2025-09-11

Locations

1 site across 1 country: Finland