Method Study: Bilateral TAP Block With 24 Hours Infusion

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pernille Lykke Petersen, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT01577940
First received: November 21, 2011
Last updated: May 3, 2012
Last verified: May 2012
  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:


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
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
HovedOrtoCentret, Rigshospitalet
Copenhagen, Denmark, 2100
HOC, anesthesiology, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Investigators
Principal Investigator: Pernille L Petersen, MD HOC, anesthesiology, Rigshospitalet, Copenhagen
  More Information

No publications provided

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
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 01, 2014