Method Study: Bilateral TAP Block With 24 Hours Infusion

Phase 4

Completed

• Conditions: Postoperative Pain
• Interventions: Procedure: Infusion of ropivacaine; Procedure: Infusion of saline

• Registration Number: NCT01577940
• Lead Sponsor: Glostrup University Hospital, Copenhagen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-11-21
• Study First Submitted QC: 2012-04-13
• Study First Posted: 2012-04-16
• Status Verified: 2012-05
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Last Update Submitted: 2012-05-03
• Last Update Posted: 2012-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Infusion of local anesthetic	Infusion of ropivacaine	TAP block with 20 ml of ropivacaine 0,5%, catheter with infusion of ropivacaine 0,2% 5 ml/h 24 hours.
Infusion of saline	Infusion of saline	TAP block with 20 ml of ropivacaine 0,5%, catheter with infusion of saline 5 ml/h 24 hours.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Heat pain detection threshold (abdomen)	-15 min., 1, 4, 8, 12 and 24 hours following TAP block	Gradually heating of the skin from 32 to 52 degrees Celcius. The participant indicates the temperature where the stimulus is painful.
Heat pain detection threshold (dominant forearm)	-15 min., 1, 4, 8, 12 and 24 hours following TAP block	Gradually heating of the skin from 32 to 52 degrees Celcius. The participant indicates the temperature where the stimulus is painful.
Long Thermal stimulation (abdomen)	-15 min., 1, 4, 8, 12 and 24 hours following TAP block	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)
Lung function	-15 min., 1, 4, 8, 12 and 24 hours following TAP block	Inspiratory and expiratory force

Trial Locations

Locations (2)

HovedOrtoCentret, Rigshospitalet; 🇩🇰 Copenhagen, Denmark

HOC, anesthesiology, Rigshospitalet; 🇩🇰 Copenhagen, Denmark