Method Study: Bilateral TAP Block With 24 Hours Infusion - Full Text View

Purpose

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	Intervention	Phase
Postoperative Pain	Procedure: Infusion of ropivacaine Procedure: Infusion of saline	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Drug Information available for: Ropivacaine monohydrochloride

U.S. FDA Resources

Further study details as provided by Glostrup University Hospital, Copenhagen:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
Extent of sensory block using pinprick and ice

Secondary Outcome Measures:

Heat pain detection threshold (abdomen) [ Time Frame: -15 min., 1, 4, 8, 12 and 24 hours following TAP block ] [ Designated as safety issue: No ]
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) [ Time Frame: -15 min., 1, 4, 8, 12 and 24 hours following TAP block ] [ Designated as safety issue: No ]
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) [ Time Frame: -15 min., 1, 4, 8, 12 and 24 hours following TAP block ] [ Designated as safety issue: Yes ]
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 [ Time Frame: -15 min., 1, 4, 8, 12 and 24 hours following TAP block ] [ Designated as safety issue: No ]
Inspiratory and expiratory force


Enrollment:	8
Study Start Date:	January 2011
Study Completion Date:	May 2012
Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility


Ages Eligible for Study:	18 Years to 30 Years (Adult)
Genders 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01577940

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


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
Study First Received:	November 21, 2011
Last Updated:	May 3, 2012
Health Authority:	Denmark: Danish Dataprotection Agency Denmark: Danish Medicines Agency Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by 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

ClinicalTrials.gov processed this record on September 28, 2016