Comparing two methods of pain management during laparoscopic gallbladder surgery
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 study is testing whether a new pain management method that combines two techniques can help people feel less pain after gallbladder surgery compared to just one technique.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 850 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Helsinki University Central Hospital Academic / other |
| Locations | 1 site (Espoo, Uusimaa) |
| Trial ID | NCT06123117 on ClinicalTrials.gov |
What this trial studies
This trial is a prospective randomized superiority trial that compares the effectiveness of local trocar site infiltration with ropivacaine to a combined approach that includes a laparoscopic transversus abdominis plane (TAP) block in patients undergoing laparoscopic cholecystectomy. The study aims to determine if the STALL method, which integrates both techniques, provides superior pain relief compared to the sole local infiltration method. The hypothesis is based on the premise that a sufficiently large sample size will reveal a significant difference in efficacy between the two approaches. The trial will include patients scheduled for elective or emergency laparoscopic cholecystectomy.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 scheduled for elective or emergency laparoscopic cholecystectomy who can provide informed consent.
Not a fit: Patients under 18, those with chronic opioid use, severe coagulopathy, or allergies to local anesthetics may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing laparoscopic cholecystectomy.
How similar studies have performed: Previous studies have shown mixed results regarding the effectiveness of TAP blocks in this context, indicating that this approach is still being explored.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Espoo, Uusimaa
- Jorvi hospital / HUS — Espoo, Uusimaa, Finland (Recruiting)
Study contacts
- Study coordinator: Roman Kornõšev, MD
- Email: roman.kornosev@hus.fi
- Phone: +358 504 279755
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.