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Postoperative pain management is essential and the inability to treat acute pain appropriately in the first 48 postoperative hours represents a risk factor for developing chronic pain. No. study has investigated Vortioxetine as an adjuvant to standard care for postoperative pain management in patients undergoing LC
Postoperative pain is a main challenge for delayed hospital discharge in Laparoscopic cholecystectomy. . Postoperative pain management is essential and the inability to treat acute pain appropriately in the first 48 postoperative hours represents a risk factor for developing chronic pain. Vortioxetine (VO) is a multimodal serotonergic antidepressant with a unique mechanism of action that is effective in treating neuropathic pain. The purpose of this study is evaluating the efficacy and tolerability of preoperative oral administration of Vortioxetine on postoperative pain control in patients undergoing LC
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm | No Intervention | The patient will not be administered with any drug/placebo before the surgery | |
| Intervention arm | Experimental | 20 mg oral vortioxetine tablet 2 hours before the procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vortioxetine 20Mg Tab | Drug | 20 mg oral vortioxetine tablet 2 hours before the procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| VAS score (Visual analogue scale) | Pain intensity: VAS score from 0 to 100 mm In which 0 means no pain, and 100 means the worst pain possible | 2 hours, 4 hours, 8 hours, 12 hours, 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to analgesic request | Time to analgesic request | 24 hours |
| Quality of life (QoL) after laparoscopic cholecystectomy (LC) | Gastrointestinal Quality of Life Index questionnaire for QOL assessment with calculation of the score; most desirable option: 4 points, least desirable option: 0 points and GIQLI score: sum of the point. GIQLI ranges from 0 to 80 with higher scores indicating a better quality of life. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Hepatology and Tropical Research Institute | Cairo | 11617 | Egypt |
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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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| ID | Term |
|---|---|
| D000078784 | Vortioxetine |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| 3 months |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |