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Completed

NCT Number: NCT03350334

Perioperative Duloxetine for Pain Management After Laparoscopic Hysterectomy

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.

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Key information

Conditions

Laparoscopic Hysterectomy Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Postoperative Recovery Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Acibadem Maslak Hospital

Sarıyer, Istanbul, 34457, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Duloxetine

Drug

Peri-operative Duloxetine administration

Other names: Cymbalta

Placebo

Drug

Placebo administration

Primary outcomes

  1. Quality of Recovery-40 questionnaire total score

    Time frame: 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 outcomes

  1. Narcotic analgesic consumption doses

    Time frame: 24 hours after surgery

    Number of total narcotic analgesic consumption doses of the participants through the post-operative 24 hours.

  2. Length of hospital stay

    Time frame: post-operative 1 week

    number of days participants stay in hospital

Sponsors and collaborators

Lead sponsor

Acibadem University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 22, 2017
Registry last updated
May 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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