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Method Study: Bilateral TAP Block With 24 Hours Infusion

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ClinicalTrials.gov Identifier: NCT01577940
Recruitment Status : Completed
First Posted : April 16, 2012
Last Update Posted : May 4, 2012
Sponsor:
Information provided by (Responsible Party):
Pernille Lykke Petersen, Glostrup University Hospital, Copenhagen

Study Description
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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

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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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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    Key Record Dates
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