STALL vs Sole Local Wound Infiltration in Laparoscopic Cholecystectomy
NCT06123117 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 850
Last updated 2025-09-11
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
- PROCEDURE
-
single transversus abdominis laparoscopy-guided plane block
please see arm/group descriptions
- PROCEDURE
-
local trocar site ropivacaine infiltration
please see arm/group descriptions
Sponsors & Collaborators
-
Helsinki University Central Hospital
lead OTHER
Principal Investigators
-
Henna Sammalkorpi, MD, PhD · Helsinki UCH
-
Hanna Lampela, MD, PhD · Helsinki UCH
-
Jukka Harju, MD, PhD, Doc · Helsinki UCH
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-01-16
- Primary Completion
- 2025-12-31
- Completion
- 2027-10-31
Countries
- Finland
Study Locations
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