Perioperative Duloxetine for Pain Management After Laparoscopic Hysterectomy

Not Applicable

Completed

• Conditions: Laparoscopic Hysterectomy; Postoperative Recovery; Postoperative Pain
• Interventions: Drug: Duloxetine; Drug: placebo

• Registration Number: NCT03350334
• Lead Sponsor: Acibadem University

Brief Summary

The aim of the investigators of the study is to evaluate the effect of peri-operative duloxetine on post-operative recovery in patients undergoing laparoscopic hysterectomy.

Detailed Description

Patients with benign gynecologic conditions (fibroids, pelvic pain, uterine prolapse) who are planned to undergo laparoscopic hysterectomy will be enrolled in the study. After randomization, the study participants will be given 60 mg duloxetine 2 hours before surgery and 24 hours after surgery, whereas the control participants will be given placebo tablets.

Study Timeline

• Study First Submitted: 2017-11-13
• Study First Submitted QC: 2017-11-21
• Study First Posted: 2017-11-22
• Study Start: 2017-12-04
• Primary Completion: 2018-03-10
• Study Completion: 2018-03-15
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-15
• Last Update Posted: 2018-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Patients with benign gynecologic conditions (fibroids, pelvic pain, uterine prolapse) who are planned to undergo laparoscopic hysterectomy will be enrolled in the study

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Exclusion Criteria

• Patients with chronic non-gynecologic conditions (liver or pulmonary disease, diabetes), using psychiatric drugs (anti-depressants, neuroleptics, lithium) in the last 1 year, those with duloxetine allergy, and patients using opioids for gynecologic or non-gynecologic conditions will be excluded from the study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Duloxetine	Duloxetine	The patients who will be given 60 mg duloxetine 2 hours before surgery and 24 hours after surgery.
Placebo Control	placebo	The patients who will be given 60 mg placebo 2 hours before surgery and 24 hours after surgery.

Primary Outcome Measures

Name	Time	Method
Quality of Recovery-40 questionnaire total score	24 hours after surgery	Total scores of the Quality of Recovery-40 scale will be obtained 24 hours after surgery. Quality of Recovery-40 scale is a validated post-operative recovery questionnaire that consists of 40 questions, and 5 sub-components for pain (7), physical comfort (12), physical independence (5), emotional state (9), and psychological support (7). Positive items are scored from 1 (worst) to 5 (best); scores are reversed for negative items. Each item is scored ranging from 1 to 5. Total questionnaire score is calculated by sum of all items, and also sub-components by the sum of corresponding items. The total score ranges from 40 to 200.

Secondary Outcome Measures

Name	Time	Method
Narcotic analgesic consumption doses	24 hours after surgery	Number of total narcotic analgesic consumption doses of the participants through the post-operative 24 hours.
Length of hospital stay	post-operative 1 week	number of days participants stay in hospital

Trial Locations

Locations (1)

Acibadem Maslak Hospital; 🇹🇷 Sariyer, Istanbul, Turkey