Method Study: Bilateral TAP Block With 24 Hours Infusion

Study Overview
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Brief Summary
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The purpose of this method study in healthy volunteers is to determine the extent of sensory block following Transversus Abdominis Plane (TAP) block with 24 hours infusion of ropivacaine versus infusion of saline. Furthermore, to determined the analgesic effect of the TAP block and the influence on the lung function.

Official Title
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Method Study of Bilateral Transversus Abdominis Plane (TAP) Block With 24 Hours Infusion. Extent of Sensory Block, Analgetic Effect and Lung Function in Healthy Volunteers

Conditions
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Postoperative Pain

Intervention / Treatment
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* Procedure: Infusion of ropivacaine
* Procedure: Infusion of saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 18 and 30 years written consent ASA 1 BMI between 18 and 25 males Exclusion Criteria: unable to communicate in Danish relevant drug allergy alcohol or/and drug abuse daily intake of prescription pain medication the last 4 weeks pain medication in the last 48 hours previously operated abdominal

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Infusion of local anesthetic<br>TAP block with 20 ml of ropivacaine 0,5%, catheter with infusion of ropivacaine 0,2% 5 ml/h 24 hours. | Procedure: Infusion of ropivacaine<br>* TAP block with ropivacaine 20 ml 0,5%. Catheter with infusion of ropivacaine 0,2% 5 ml/h 24 hours on one side of the abdomen.<br>|
| Placebo Comparator: Infusion of saline<br>TAP block with 20 ml of ropivacaine 0,5%, catheter with infusion of saline 5 ml/h 24 hours. | Procedure: Infusion of saline<br>* TAP block with ropivacaine 0,5% 20 ml. Catheter with infusion of saline 5 ml/h 24 hours.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in extend of sensory block from baseline (pre block) to 24 hours post block, based on 6 measurements | Extent of sensory block using pinprick and ice | -15 min., 1, 4, 8, 12 and 24 hours following TAP block | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heat pain detection threshold (abdomen) | Gradually heating of the skin from 32 to 52 degrees Celcius. The participant indicates the temperature where the stimulus is painful. | -15 min., 1, 4, 8, 12 and 24 hours following TAP block | 
| Heat pain detection threshold (dominant forearm) | Gradually heating of the skin from 32 to 52 degrees Celcius. The participant indicates the temperature where the stimulus is painful. | -15 min., 1, 4, 8, 12 and 24 hours following TAP block | 
| Long Thermal stimulation (abdomen) | Heating of the skin, 45 degrees Celsius 1 minute. The participant indicates pain scores on a Visuel Analog Scale from 0 (no pain) to 100 (worst imaginable) | -15 min., 1, 4, 8, 12 and 24 hours following TAP block | 
| Lung function | Inspiratory and expiratory force | -15 min., 1, 4, 8, 12 and 24 hours following TAP block | 

 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, Postoperative pain management