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Method Study: Bilateral TAP Block With 24 Hours Infusion

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Infusion of ropivacaine
Infusion of saline
Sponsored by
Glostrup University Hospital, Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Transversus abdominis plane block, postoperative pain, Postoperative pain management

Eligibility Criteria

18 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • HOC, anesthesiology, Rigshospitalet
  • HovedOrtoCentret, Rigshospitalet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Infusion of local anesthetic

Infusion of saline

Arm Description

TAP block with 20 ml of ropivacaine 0,5%, catheter with infusion of ropivacaine 0,2% 5 ml/h 24 hours.

TAP block with 20 ml of ropivacaine 0,5%, catheter with infusion of saline 5 ml/h 24 hours.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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)
Lung function
Inspiratory and expiratory force

Full Information

First Posted
November 21, 2011
Last Updated
May 3, 2012
Sponsor
Glostrup University Hospital, Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT01577940
Brief Title
Method Study: Bilateral TAP Block With 24 Hours Infusion
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 Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Glostrup University Hospital, Copenhagen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Transversus abdominis plane block, postoperative pain, Postoperative pain management

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Infusion of local anesthetic
Arm Type
Experimental
Arm Description
TAP block with 20 ml of ropivacaine 0,5%, catheter with infusion of ropivacaine 0,2% 5 ml/h 24 hours.
Arm Title
Infusion of saline
Arm Type
Placebo Comparator
Arm Description
TAP block with 20 ml of ropivacaine 0,5%, catheter with infusion of saline 5 ml/h 24 hours.
Intervention Type
Procedure
Intervention Name(s)
Infusion of ropivacaine
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Infusion of saline
Intervention Description
TAP block with ropivacaine 0,5% 20 ml. Catheter with infusion of saline 5 ml/h 24 hours.
Primary Outcome Measure Information:
Title
Change in extend of sensory block from baseline (pre block) to 24 hours post block, based on 6 measurements
Description
Extent of sensory block using pinprick and ice
Time Frame
-15 min., 1, 4, 8, 12 and 24 hours following TAP block
Secondary Outcome Measure Information:
Title
Heat pain detection threshold (abdomen)
Description
Gradually heating of the skin from 32 to 52 degrees Celcius. The participant indicates the temperature where the stimulus is painful.
Time Frame
-15 min., 1, 4, 8, 12 and 24 hours following TAP block
Title
Heat pain detection threshold (dominant forearm)
Description
Gradually heating of the skin from 32 to 52 degrees Celcius. The participant indicates the temperature where the stimulus is painful.
Time Frame
-15 min., 1, 4, 8, 12 and 24 hours following TAP block
Title
Long Thermal stimulation (abdomen)
Description
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)
Time Frame
-15 min., 1, 4, 8, 12 and 24 hours following TAP block
Title
Lung function
Description
Inspiratory and expiratory force
Time Frame
-15 min., 1, 4, 8, 12 and 24 hours following TAP block

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pernille L Petersen, MD
Organizational Affiliation
HOC, anesthesiology, Rigshospitalet, Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
HOC, anesthesiology, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
HovedOrtoCentret, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
24106815
Citation
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.
Results Reference
derived

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Method Study: Bilateral TAP Block With 24 Hours Infusion

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