RecruitingNot ApplicableNCT06123117

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.


Sponsor

Helsinki University Central Hospital

Enrollment

850 participants

Start Date

Jan 16, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria1

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

Exclusion Criteria1

  • 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.

Interventions

PROCEDUREsingle transversus abdominis laparoscopy-guided plane block

please see arm/group descriptions

PROCEDURElocal trocar site ropivacaine infiltration

please see arm/group descriptions


Locations(1)

Jorvi hospital / HUS

Espoo, Uusimaa, Finland

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NCT06123117


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