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NCT Number: NCT06123117

STALL vs Sole Local Wound Infiltration in Laparoscopic Cholecystectomy

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.

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Key information

Conditions

Cholelithiasis Biliary Tract Diseases Biliary Tract Neoplasms Cholecystitis Digestive System Diseases Digestive System Neoplasms Gallbladder Cancer Gallbladder Diseases Gallbladder Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

single transversus abdominis laparoscopy-guided plane block

Procedure

please see arm/group descriptions

Other names: STALL

local trocar site ropivacaine infiltration

Procedure

please see arm/group descriptions

Primary outcomes

  1. cumulative opioid consumption during the stay at the recovery

    Time frame: duration of stay at the recovery (estimated 1-4 hours)

    all groups; mg, morphine equivalent

Secondary outcomes

  1. maximum NRS score during the day of surgery, after discharge (daycare / outpatient)

    Time frame: 30 min after surgery, every 60 min afterwards; 2 days

    NRS (Numerical Rating Scale): 0-10

  2. cumulative opioid consumption (emergency and inpatient surgery)

    Time frame: while admitted; est. 2 days

    mg, morphine equivalent

Other outcomes

  1. maximum NRS score during the stay at the recovery

    Time frame: until the patient is either discharged to ward or home (day surgery patients), est. 1-4 hours

    0-10

  2. average NRS score during the stay at the recovery

    Time frame: duration of stay at the recovery, est. 1-4 hours

    0-10

  3. NRS score in multiple time points

    Time frame: every hour until discharge and at discharge = "ready to go" / "ready for transfer" (during in-hospital care), est. 48 hours

    if awake

  4. procedure time

    Time frame: minutes; est. 60 - 180 minutes

    min

  5. time necessary in recovery room

    Time frame: minutes; est. 60 - 260 min

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

  6. complications related to the use of local anesthetics

    Time frame: est. 0 - 7 days

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

  7. patient general satisfaction with pain management

    Time frame: prespecified: about 4 hours, 2 days, 7 days, 30 days

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

  8. time from surgery to discharge

    Time frame: est. 2 - 48 hours

    min

  9. number of patients contacting the hospital regarding inadequate pain management

    Time frame: after discharge and before day 30

    n

  10. prevalence of postoperative nausea and vomiting (PONV) and difference in subgroups

    Time frame: est. 0 - 4 (8) hours

    n; %

  11. difference in NRS (if any) between patients received remifentanil or fentanyl intraoperatively

    Time frame: 0 - 4 hours

    delta

  12. difference in NRS (if any) between patients received propofol or sevoflurane maintenance.

    Time frame: 0- 4 hours

    delta

  13. pain-control failure & possible causes

    Time frame: acute: 0 - 2 days; chronic: t+30 days

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

Study contacts

Contact information is provided by the study sponsor or research team.

Alexey Schramko, MD, PhD, Doc

CONTACT

[email protected]

+358 504 270610

Roman Kornõšev, MD

CONTACT

[email protected]

+358 504 279755

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study title

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.

Acronym: STALL

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Nov 8, 2023
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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