Perioperative Duloxetine for Pain Management After Laparoscopic Hysterectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Perioperative Duloxetine for Pain Management After Laparoscopic Hysterectomy: A Prospective Randomized Placebo-controlled Study

Conditions
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Laparoscopic Hysterectomy, Postoperative Recovery, Postoperative Pain

Intervention / Treatment
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* Drug: Duloxetine
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomised
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Duloxetine<br>The patients who will be given 60 mg duloxetine 2 hours before surgery and 24 hours after surgery. | Drug: Duloxetine<br>* Peri-operative Duloxetine administration<br>* Other names: Cymbalta;|
| Placebo Comparator: Placebo Control<br>The patients who will be given 60 mg placebo 2 hours before surgery and 24 hours after surgery. | Drug: placebo<br>* Placebo administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Recovery-40 questionnaire total score | 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. | 24 hours after surgery | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Duloxetine, laparoscopic hysterectomy, postoperative pain, postoperative recovery