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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-017420-75 | EudraCT Number |
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The purpose of this study is to determine whether Transversus abdominis plane block as part of a multimodal postoperative regimen is superior to control in analgesic efficacy after laparoscopic cholecystectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| transversus abdominis plane block | Experimental | transversus abdominis plane block with ropivacaine |
|
| block with saline | Placebo Comparator | 20 ml of isotonic saline bilateral |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transversus abdominis plane block | Procedure | UL-guided TAP block with 20 ml of ropivacaine 0,5% bilateral, single dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain during cough. | Area under the curve (AUC)-pain during cough based on measurements at 0,2,4,6,8,24 hours postoperative. | 0,2,4,6,8,24 hours postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Pain during rest | Area under the curve (AUC)-pain during rest based on measurements at 0,2,4,6,8,24 hours postoperative. | 0,2,4,6,8,24 hours postoperative |
| Total opioid consumption | Morphine consumption 0-2 hours postoperative. Ketobemidone consumption 2-24 hours postoperative. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pernille L Petersen, MD | Glostrup University Hospital, Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glostrup University Hospital, Department of anesthesia | Glostrup Municipality | 2600 | Denmark |
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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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| TAP block placebo | Procedure | UL-guided TAP block with 20 ml of saline bilaterally, single dose. |
|
|
| 0-24 hours postoperative |
| Postoperative nausea and vomiting | Nausea scores (0-3) at 0,2,4,6,8,24 hours postoperative. The number of vomits 0-2, 2-4, 4-6, 6-8 and 8-24 hours postoperative | 0,2,4,6,8,24 hours postoperative |
| Sedation | Sedation scores (0-3) at 0,2,4,6,8,24 hours postoperative | 0,2,4,6,8,24 hours postoperative |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |