Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06123117

Single Transversus Abdominis Laparoscopy-guided Plane Block Combined With Local Trocar Site Ropivacaine Infiltration (STALL) versus Local Wound Infiltration Alone in Laparoscopic Cholecystectomy: A Double-blinded Randomized Controlled Trial

Led by Helsinki University Central Hospital · Updated on 2025-09-11

850

Participants Needed

1

Research Sites

95 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of two pain management methods in patients undergoing laparoscopic cholecystectomy (LCC), which is surgery to remove the gallbladder. The study aims to compare the use of local ropivacaine infiltration at trocar sites alone versus combined with a laparoscopically guided transversus abdominis plane (TAP) block, called the STALL technique. This randomized controlled trial is designed to determine if STALL provides better pain relief than local infiltration alone, as previous smaller trials have not shown clear benefits of TAP block. Participants will be assigned to one of six groups based on their surgery type: daycare, in-patient, or emergency surgery. Each group will either receive local ropivacaine infiltration alone or combined with the laparoscopic TAP block. The study treatments involve procedures performed during surgery to manage post-operative pain. Both methods use ropivacaine, a local anesthetic, applied either just at the wound sites or also via the TAP block guided by laparoscopy. During the study, researchers will monitor participants' opioid use during recovery, which lasts approximately 1 to 4 hours, and record pain scores using the Numeric Rating Scale for up to two days after surgery. Opioid consumption will also be tracked for inpatient and emergency surgery patients while admitted, estimated at about two days. The study is double-blinded and randomized to ensure unbiased results. Participants will be followed throughout their hospital stay and recovery period to assess pain control and medication needs.

CONDITIONS

Brief Title

STALL vs Sole Local Wound Infiltration in Laparoscopic Cholecystectomy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients scheduled for elective or emergency laparoscopic cholecystectomy
  • Age over 18 years
  • Able to give informed consent
Not Eligible

You will not qualify if you...

  • Age under 18 years
  • Daily opioid use or abuse of pain-modifying medications
  • Pregnancy
  • Known allergy to local anesthetics
  • Diagnosed severe coagulopathy
  • Unable to give informed consent for any reason

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - 1 to 4 hours

Participants undergo laparoscopic cholecystectomy with either STALL (single transversus abdominis laparoscopy-guided plane block combined with local trocar site ropivacaine infiltration) or local wound infiltration alone, followed by immediate recovery monitoring.

1 surgery and recovery visit

Post-operative Follow-up

Duration - Up to 2 days

Participants are monitored for pain and opioid consumption after discharge for daycare and outpatient patients, or while admitted for emergency and inpatient surgery patients.

Pain assessments every 30 minutes after surgery then every 60 minutes for 2 days for daycare/outpatient; daily monitoring for emergency and inpatient patients

Trial Site Locations

Total: 1 location

1

Jorvi hospital / HUS

Espoo, Uusimaa, Finland, 00029

Actively Recruiting

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Research Team

R

Roman Kornõšev, MD

A

Alexey Schramko, MD, PhD, Doc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

6

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Frequently Asked Questions

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Published Research Related To This Trial

Local infiltration versus laparoscopic-guided transverse abdominis plane block in laparoscopic cholecystectomy: double-blinded randomized control trial.

Rohan C Siriwardana, Sumudu K Kumarage, Bhagya M Gunathilake...

https://pubmed.ncbi.nlm.nih.gov/29943054

Purely ropivacaine-based TEA vs single TAP block in pain management after elective laparoscopic colon surgery within an upgraded institutional ERAS program.

Vilma Bumblyte, Suvi K Rasilainen, Anu Ehrlich...

https://pubmed.ncbi.nlm.nih.gov/34480217

Laparoscopic-Guided Transversus Abdominis Plane (TAP) Block as Part of Multimodal Analgesia in Laparoscopic Roux-en-Y Gastric Bypass Within an Enhanced Recovery After Surgery (ERAS) Program: a Prospective Randomized Clinical Trial.

Jaime Ruiz-Tovar, Alejandro Garcia, Carlos Ferrigni...

https://pubmed.ncbi.nlm.nih.gov/29980989

Ultrasound-Guided Transversus Abdominis Plane Block for Analgesia in Laparoscopic Cholecystectomy: A Systematic Review and Meta-Analysis.

Ke Peng, Fu-hai Ji, Hua-yue Liu...

https://pubmed.ncbi.nlm.nih.gov/26885872

The efficacy of oblique subcostal transversus abdominis plane block in laparoscopic cholecystectomy - a prospective, placebo controlled study.

Caius Mihai Breazu, Lidia Ciobanu, Adina Hadade...

https://pubmed.ncbi.nlm.nih.gov/28913472

Efficacy of a Laparoscopically Delivered Transversus Abdominis Plane Block Technique during Elective Laparoscopic Cholecystectomy: A Prospective, Double-Blind Randomized Trial.

Ghassan Elamin, Peadar S Waters, Hytham Hamid...

https://pubmed.ncbi.nlm.nih.gov/25899736

Efficacy of the subcostal transversus abdominis plane block in laparoscopic cholecystectomy: Comparison with conventional port-site infiltration.

S Tolchard, R Davies, S Martindale

https://pubmed.ncbi.nlm.nih.gov/22869941

Bilateral transversus abdominis plane block does not decrease postoperative pain after laparoscopic cholecystectomy when compared with local anesthetic infiltration of trocar insertion sites.

Jaime Ortiz, James W Suliburk, Kenneth Wu...

https://pubmed.ncbi.nlm.nih.gov/22330261

Analgesic efficacy of ultrasound guided transversus abdominis plane block versus local anesthetic infiltration in adult patients undergoing single incision laparoscopic cholecystectomy: A randomized controlled trial.

Ejas P Bava, Rashmi Ramachandran, Vimi Rewari...

https://pubmed.ncbi.nlm.nih.gov/27746552