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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cholelithiasis
- Sponsor
- Helsinki University Central Hospital
- Enrollment
- 850
- Locations
- 1
- Primary Endpoint
- cumulative opioid consumption during the stay at the recovery
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
Brief 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.
Investigators
Roman Kornosev
MD
Helsinki University Central Hospital
Eligibility 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.
Outcomes
Primary Outcomes
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
- cumulative opioid consumption (emergency and inpatient surgery)(while admitted; est. 2 days)
- maximum NRS score during the day of surgery, after discharge (daycare / outpatient)(30 min after surgery, every 60 min afterwards; 2 days)