STALL vs Sole Local Wound Infiltration in Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Cholecystitis, Cholelithiasis, Gallbladder Cancer

Intervention / Treatment
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* Procedure: single transversus abdominis laparoscopy-guided plane block
* Procedure: local trocar site ropivacaine infiltration


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients are analyzed following the intention to treat in three subgroups: Patients treated in day-care outpatient surgical unit (DS): TAP+local vs local. Patients treated electively in the inpatient surgery unit (IS): TAP+local vs local. Emergency surgery patients (ES): TAP+local vs local.
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cumulative opioid consumption during the stay at the recovery | 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) | NRS (Numerical Rating Scale): 0-10 | 30 min after surgery, every 60 min afterwards; 2 days | 
| cumulative opioid consumption (emergency and inpatient surgery) | mg, morphine equivalent | while admitted; est. 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopic transversus abdominis plane block