STALL vs Sole Local Wound Infiltration in Laparoscopic Cholecystectomy (STALL)

January 19, 2024 updated by: Roman Kornosev, Helsinki University Central Hospital

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

850

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Finland
    • Karvasmäentie 8
      • Espoo, Karvasmäentie 8, Finland, 02740

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Daycare: STALL
Local ropivacaine infiltration + laparoscopically controlled TAP (transversus abdominis plane block). Daycare patients.
Procedure: single transversus abdominis laparoscopy-guided plane block
please see arm/group descriptions
Other Names:
  • STALL
Procedure: local trocar site ropivacaine infiltration
please see arm/group descriptions
Active Comparator: Daycare: local only
Local ropivacaine infiltration only. Daycare patients.
Procedure: local trocar site ropivacaine infiltration
please see arm/group descriptions
Experimental: In-patient: STALL
Local ropivacaine infiltration + laparoscopically controlled TAP. In-patient surgery.
Procedure: single transversus abdominis laparoscopy-guided plane block
please see arm/group descriptions
Other Names:
  • STALL
Procedure: local trocar site ropivacaine infiltration
please see arm/group descriptions
Active Comparator: In-patient: local only
Local ropivacaine infiltration only. In-patient surgery.
Procedure: local trocar site ropivacaine infiltration
please see arm/group descriptions
Experimental: Emergency: STALL
Local ropivacaine infiltration + laparoscopically controlled TAP. Emergency patients.
Procedure: single transversus abdominis laparoscopy-guided plane block
please see arm/group descriptions
Other Names:
  • STALL
Procedure: local trocar site ropivacaine infiltration
please see arm/group descriptions
Active Comparator: Emergency: local only
Local ropivacaine infiltration only. Emergency patients.
Procedure: local trocar site ropivacaine infiltration
please see arm/group descriptions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
duration of stay at the recovery (estimated 1-4 hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 min after surgery, every 60 min afterwards; 2 days
cumulative opioid consumption (emergency and inpatient surgery)
Time Frame: while admitted; est. 2 days
mg, morphine equivalent
while admitted; est. 2 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
until the patient is either discharged to ward or home (day surgery patients), est. 1-4 hours
average NRS score during the stay at the recovery
Time Frame: duration of stay at the recovery, est. 1-4 hours
0-10
duration of stay at the recovery, est. 1-4 hours
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
every hour until discharge and at discharge = "ready to go" / "ready for transfer" (during in-hospital care), est. 48 hours
procedure time
Time Frame: minutes; est. 60 - 180 minutes
min
minutes; est. 60 - 180 minutes
time necessary in recovery room
Time Frame: minutes; est. 60 - 260 min
min, (= "patient ready to be discharged" timestamp OR "patient ready for transfer")
minutes; est. 60 - 260 min
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
est. 0 - 7 days
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
prespecified: about 4 hours, 2 days, 7 days, 30 days
time from surgery to discharge
Time Frame: est. 2 - 48 hours
min
est. 2 - 48 hours
number of patients contacting the hospital regarding inadequate pain management
Time Frame: after discharge and before day 30
n
after discharge and before day 30
prevalence of postoperative nausea and vomiting (PONV) and difference in subgroups
Time Frame: est. 0 - 4 (8) hours
n; %
est. 0 - 4 (8) hours
difference in NRS (if any) between patients received remifentanil or fentanyl intraoperatively
Time Frame: 0 - 4 hours
delta
0 - 4 hours
difference in NRS (if any) between patients received propofol or sevoflurane maintenance.
Time Frame: 0- 4 hours
delta
0- 4 hours
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
acute: 0 - 2 days; chronic: t+30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Investigators

  • Study Director: Henna Sammalkorpi, MD, PhD, Helsinki UCH
  • Study Director: Hanna Lampela, MD, PhD, Helsinki UCH
  • Study Director: Jukka Harju, MD, PhD, Doc, Helsinki UCH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

November 5, 2023

First Submitted That Met QC Criteria

November 5, 2023

First Posted (Actual)

November 8, 2023

Study Record Updates

Last Update Posted (Estimated)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 19, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7351

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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