Laparoscopic Hysterectomy, Postoperative Pain, Postoperative Recovery
Conditions
Keywords
Duloxetine, laparoscopic hysterectomy, postoperative pain, postoperative recovery
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.
Interventions
DRUGDuloxetine
Peri-operative Duloxetine administration
DRUGplacebo
Placebo administration
Sponsors
Acibadem University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants do not know whether they take placebo or Duloxetine
Intervention model description
Prospective randomised
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Turkey (Türkiye)
Outcome results
None listed