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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005118-13 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infusion of local anesthetic | Experimental | TAP block with 20 ml of ropivacaine 0,5%, catheter with infusion of ropivacaine 0,2% 5 ml/h 24 hours. |
|
| Infusion of saline | Placebo Comparator | TAP block with 20 ml of ropivacaine 0,5%, catheter with infusion of saline 5 ml/h 24 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infusion of ropivacaine | Procedure | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | -15 min., 1, 4, 8, 12 and 24 hours following TAP block |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | -15 min., 1, 4, 8, 12 and 24 hours following TAP block |
| Heat pain detection threshold (dominant forearm) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pernille L Petersen, MD | HOC, anesthesiology, Rigshospitalet, Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HOC, anesthesiology, Rigshospitalet | Copenhagen | 2100 | Denmark | |||
| HovedOrtoCentret, Rigshospitalet |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24106815 | Derived | 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. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| Infusion of saline | Procedure | TAP block with ropivacaine 0,5% 20 ml. Catheter with infusion of saline 5 ml/h 24 hours. |
|
Gradually heating of the skin from 32 to 52 degrees Celcius. The participant indicates the temperature where the stimulus is painful. |
| -15 min., 1, 4, 8, 12 and 24 hours following TAP block |
| 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) | -15 min., 1, 4, 8, 12 and 24 hours following TAP block |
| Lung function | Inspiratory and expiratory force | -15 min., 1, 4, 8, 12 and 24 hours following TAP block |
| Copenhagen |
| 2100 |
| Denmark |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |