Method Study: Bilateral TAP Block With 24 Hours Infusion

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: Infusion of ropivacaine; Procedure: Infusion of saline

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • HovedOrtoCentret, Rigshospitalet
  • Copenhagen, Denmark, 2100
    • HOC, anesthesiology, Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Infusion of local anesthetic; 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; 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.
Placebo Comparator: Infusion of saline; TAP block with 20 ml of ropivacaine 0,5%, catheter with infusion of saline 5 ml/h 24 hours.	Procedure: Infusion of saline; TAP block with ropivacaine 0,5% 20 ml. Catheter with infusion of saline 5 ml/h 24 hours.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Glostrup University Hospital, Copenhagen
• Investigators: Principal Investigator: Pernille L Petersen, MD, HOC, anesthesiology, Rigshospitalet, Copenhagen

Publications and helpful links

General Publications

• Petersen PL, Hilsted KL, Dahl JB, Mathiesen O. Bilateral transversus abdominis plane (TAP) block with 24 hours ropivacaine infusion via TAP catheters: A randomized trial in healthy volunteers. BMC Anesthesiol. 2013 Oct 10;13(1):30. doi: 10.1186/1471-2253-13-30.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: November 21, 2011
• First Submitted That Met QC Criteria: April 13, 2012
• First Posted (Estimate): April 16, 2012

Study Record Updates

• Last Update Posted (Estimate): May 4, 2012
• Last Update Submitted That Met QC Criteria: May 3, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: postoperative pain; Transversus abdominis plane block; Postoperative pain management
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: SM1-PLP-11; 2011-005118-13 (EudraCT Number)