Venlafaxine for Postoperative Pain of Laparoscopic Cholecystectomy

NCT05884268 — Phase 1 / Phase 2, Unknown, 60 participants, Mansoura University

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Evaluating Safety and Tolerability of Venlafaxine for Postoperative Pain of Laparoscopic Cholecystectomy

Registry	NCT05884268
Status	Unknown
Phase	Phase 1 / Phase 2
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	60 (Estimated)
Sponsor	Mansoura University (Other)
Conditions	Laparoscopic Cholecystectomy
Interventions	Venlafaxine, Placebo (Drug)
Dates	start 2023-05-30 (estimated), primary completion 2024-01-30 (estimated), completion 2024-01-30 (estimated), first posted 2023-06-01, last updated 2023-06-01

-Summary

Recent studies on the impact of perioperative venlafaxine for treatment of acute postoperative pain have yielded positive outcomes . The aim of the present study is to investigate the role of perioperative venlafaxine on the management of postoperative pain in patients undergoing LC.

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+Arms and interventions

Arm	Type	Interventions	Description
Laparoscopic Cholecystectomy	Active comparator	Drug: Venlafaxine
Control	Placebo comparator	Drug: Placebo

Venlafaxine (Drug): Patients scheduled for elective LC will receive 150 mg venlafaxine before surgery
Placebo (Drug): Patients scheduled for elective LC will receive placebo venlafaxine before surgery

+Outcome measures

Primary outcomes

Change in postoperative pain between the two groups using visual analogue score (VAS) [24 Hours postoperative]: pain will be assessed using visual analogue score (VAS) 0-100 mm (0 indicated no pain, 100 denoted the most severe pain) pain will be assessed using visual analogue score (VAS) 0-100 mm (0 indicated no pain, 100 denoted the most severe pain)

Secondary outcomes

Postoperative nausea and vomiting (PONV) [24 Hours postoperative]: 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.

+Eligibility

Sex: All, ages: 18 Years to 75 Years

Inclusion Criteria:

* 1\. Patients who are scheduled to undergo elective LC

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