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Randomized controlled trial on laparoscopic cholecystectomy. Interventional group: preincisional infiltration with levobupivacaine. Control group: no local infiltration.
Postoperative pain with numeric rating scale is registered, besides other parameters like heart rate, blood pressure, rescue analgesia requirements, nausea and vomiting, etc.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Local infiltration | Experimental |
| |
| No local infiltration | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preincisional infiltration with levobupivacaine | Drug | Local, preincisional infiltration of port sites with levobupivacaine 5 mg/ml 20 ml |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain assessed by visual numeric scale. | Values come from 0 to 10, where 0 means no pain and 10 means the worst imaginable pain. Best outcome would be 0 or close to 0 | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative administration of analgesics | Record of dose of analgesics needed: nonsteroidal anti-inflamatory drugs, opioid requirements, other analgesics requirements | 24 hours |
| Postoperative nausea and vomiting episodes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MANUEL DURÁN POVEDA, MD | H. U. REY JUAN CARLOS | Study Director |
| GIL RODRÍGUEZ CARAVACA, MD | H. F. ALCORCÓN | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Móstoles | Móstoles | Madrid | 28935 | Spain |
All IPD that underlie results in a publication
March 2022. 6 months.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 9, 2023 | |
| Reset | Feb 8, 2024 | |
| Release | Feb 12, 2024 | |
| Reset | Jul 25, 2024 | |
| Release | Jan 9, 2025 | |
| Reset | Jan 13, 2025 | |
| Release | Apr 11, 2026 | |
| Reset | Apr 14, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 9, 2023 | Feb 8, 2024 | |||
| Feb 12, 2024 |
| 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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| ID | Term |
|---|---|
| D000077554 | Levobupivacaine |
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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Record of episodes of nausea or vomiting during first 24 postoperative hours
| 24 hours |
| Jul 25, 2024 |
| Jan 9, 2025 | Jan 13, 2025 |
| Apr 11, 2026 | Apr 14, 2026 |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |