Method Study: Bilateral TAP Block With 24 Hours Infusion

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Postoperative Pain	Procedure: Infusion of ropivacaine; Procedure: Infusion of saline	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	8 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	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
Study Start Date :	January 2011
Actual Primary Completion Date :	May 2012
Actual Study Completion Date :	May 2012

Arms and Interventions

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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.

Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Heat pain detection threshold (abdomen) [ Time Frame: -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.
2. Heat pain detection threshold (dominant forearm) [ Time Frame: -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.
3. Long Thermal stimulation (abdomen) [ Time Frame: -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)
4. Lung function [ Time Frame: -15 min., 1, 4, 8, 12 and 24 hours following TAP block ]
   Inspiratory and expiratory force

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 30 Years (Adult)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

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Locations

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

Sponsors and Collaborators

Glostrup University Hospital, Copenhagen

Investigators

Principal Investigator:	Pernille L Petersen, MD	HOC, anesthesiology, Rigshospitalet, Copenhagen

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Pernille Lykke Petersen, Principal investigator, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:	NCT01577940 History of Changes
Other Study ID Numbers:	SM1-PLP-11; 2011-005118-13 ( EudraCT Number )
First Posted:	April 16, 2012
Last Update Posted:	May 4, 2012
Last Verified:	May 2012

Keywords provided by Pernille Lykke Petersen, Glostrup University Hospital, Copenhagen:

Transversus abdominis plane block; postoperative pain; Postoperative pain management

Additional relevant MeSH terms:

Pain, Postoperative; Pain; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Signs and Symptoms	Ropivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents