Perioperative Duloxetine for Pain Management After Laparoscopic Hysterectomy

Acibadem University

Status: Completed

Conditions: Postoperative Pain; Postoperative Recovery; Laparoscopic Hysterectomy

Treatments: Drug: placebo; Drug: Duloxetine

Study type: Interventional

Funder types: Other

Identifiers

NCT03350334

Ob&Gyn Maslak

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

100 participants in 2 patient groups, including a placebo group

Duloxetine

Active Comparator group

Description:

The patients who will be given 60 mg duloxetine 2 hours before surgery and 24 hours after surgery.

Treatment:

Drug: Duloxetine

Placebo Control

Placebo Comparator group

Description:

The patients who will be given 60 mg placebo 2 hours before surgery and 24 hours after surgery.

Treatment:

Drug: placebo