The Analgesic Efficacy of Transversus Abdominis Plane Block After Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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The purpose of this study is to determine whether Transversus abdominis plane block as part of a multimodal postoperative regimen is superior to control in analgesic efficacy after laparoscopic cholecystectomy.

Official Title
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The Analgesic Efficacy of Transversus Abdominis Plane Block After Laparoscopic Cholecystectomy: A Randomized Controlled Trial

Conditions
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Laparoscopic Cholecystectomy

Intervention / Treatment
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* Procedure: transversus abdominis plane block
* Procedure: TAP block placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Laparoscopic cholecystectomy ASA 1-3 BMI 18-35 Written consent Exclusion Criteria: Do not understand danish Drug allergy Pregnancy Alcohol or drug abuse Chronic pain with consumption of opioids Consumption of NSAID, COX2inhibitors or paracetamol within 24 hours before the investigation Infection at the needle site.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: transversus abdominis plane block<br>transversus abdominis plane block with ropivacaine | Procedure: transversus abdominis plane block<br>* UL-guided TAP block with 20 ml of ropivacaine 0,5% bilateral, single dose.<br>* Other names: UL-guided nerve block;|
| Placebo Comparator: block with saline<br>20 ml of isotonic saline bilateral | Procedure: TAP block placebo<br>* UL-guided TAP block with 20 ml of saline bilaterally, single dose.<br>* Other names: placebo block;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain during cough. | Area under the curve (AUC)-pain during cough based on measurements at 0,2,4,6,8,24 hours postoperative. | 0,2,4,6,8,24 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain during rest | Area under the curve (AUC)-pain during rest based on measurements at 0,2,4,6,8,24 hours postoperative. | 0,2,4,6,8,24 hours postoperative | 
| Total opioid consumption | Morphine consumption 0-2 hours postoperative. Ketobemidone consumption 2-24 hours postoperative. | 0-24 hours postoperative | 
| Postoperative nausea and vomiting | Nausea scores (0-3) at 0,2,4,6,8,24 hours postoperative. The number of vomits 0-2, 2-4, 4-6, 6-8 and 8-24 hours postoperative | 0,2,4,6,8,24 hours postoperative | 
| Sedation | Sedation scores (0-3) at 0,2,4,6,8,24 hours postoperative | 0,2,4,6,8,24 hours postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transversus abdominis plane block, postoperative pain.