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| Name | Class |
|---|---|
| National Hepatology & Tropical Medicine Research Institute | OTHER_GOV |
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Recent studies on the impact of perioperative duloxetine for treatment of acute postoperative pain have yielded positive outcomes with respect to reduction opioid consumption. The aim of the present study is to investigate the role of perioperative duloxetine on the management of postoperative pain in patients undergoing LC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Active Comparator | patients scheduled for elective LC will receive 60 mg duloxetine before surgery |
|
| Control | Placebo Comparator | patients scheduled for elective LC will receive placebo before surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duloxetine | Drug | 60 mg duloxetine |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in postoperative pain between the two groups using visual analogue score (VAS) | pain will be assessed using visual analogue score (VAS) 0-100 mm (0 indicated no pain, 100 denoted the most severe pain) | 24 Hours postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative nausea and vomiting (PONV) | will be assessed using PONV scale a 4-point scale: none (0): no nausea, vomiting, and retching; mild (1): happened once; moderate (2): happened 2-3 times; and severe (3): continuous or more than three times. | 24 Hours postoperative |
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Inclusion Criteria:
Exclusion Criteria:
1- Patients with acute pancreatitis 2. Patients undergoing chronic pain treatment 3. Patients who received analgesics or sedatives 24 h before scheduled surgery 3. Patients had alcohol or drug addiction 4. Severe hepatic and renal dysfunction 5. Previous allergic response to duloxetine 6. Pregnancy and lactation 7. Patients with communication problems, cognitive dysfunction, or psychological disorders
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura University | Al Mansurah | 35516 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36249765 | Derived | Mansour NO, Boraii S, Elnaem MH, Elrggal ME, Omar T, Abdelraouf A, Abdelaziz DH. Evaluation of preoperative duloxetine use for postoperative analgesia following laparoscopic cholecystectomy: A randomized controlled trial. Front Pharmacol. 2022 Sep 29;13:944392. doi: 10.3389/fphar.2022.944392. eCollection 2022. |
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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 |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Drug |
Placebo |
|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |