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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Postoperative Pain | Procedure: Infusion of ropivacaine Procedure: Infusion of saline | Phase 4 |
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 |

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.
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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.
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Placebo Comparator: Infusion of saline
TAP block with 20 ml of ropivacaine 0,5%, catheter with infusion of saline 5 ml/h 24 hours.
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Procedure: Infusion of saline
TAP block with ropivacaine 0,5% 20 ml. Catheter with infusion of saline 5 ml/h 24 hours.
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- 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
- 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

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Ages Eligible for Study: | 18 Years to 30 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
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

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
Denmark | |
HOC, anesthesiology, Rigshospitalet | |
Copenhagen, Denmark, 2100 | |
HovedOrtoCentret, Rigshospitalet | |
Copenhagen, Denmark, 2100 |
Principal Investigator: | Pernille L Petersen, MD | HOC, anesthesiology, Rigshospitalet, Copenhagen |
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 |