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Method Study: Bilateral TAP Block With 24 Hours Infusion
This study has been completed.
Sponsor:
Glostrup University Hospital, Copenhagen
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
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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 Intervention Model: Crossover Assignment Masking: Double Blind (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 |
Resource links provided by NLM:
Further study details as provided by Pernille Lykke Petersen, 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 ]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 ]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 ]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 ]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 ]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) |
| 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01577940
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
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 ) |
| Study First Received: | November 21, 2011 |
| Last Updated: | May 3, 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 |
ClinicalTrials.gov processed this record on June 28, 2017