Clinical trial

Evaluating the Efficacy and Safety of Preoperative Administration of Duloxetine for Pain Management in Women Undergoing Vaginal Hysterectomy.

Name
Muğla-77
Description
Vaginal hysterectomy is the preferred route of choice for women desiring hysterectomy to treat uterine pathology, including premalignant conditions and fibroids. Compared with an abdominal or a laparoscopic approach, VH has been associated with a shorter recovery time and faster return to daily activities. However, management of postoperative pain still remains challenging for patients undergoing VH. Duloxetine is a serotonin-norepinephrine reuptake inhibitor commonly prescribed for the treatment of major depression and anxiety. Duloxetine also has been used in the treatment of chronic pain conditions, such as osteoarthritis and musculoskeletal pain In contrast, studies examining its use to ameliorate acute postoperative pain are limited to a single trial.12 More importantly, it remains to be determined whether perioperative duloxetine can improve the global quality of recovery after surgery. The study included the hypothesis that perioperative duloxetine would ease postoperative recovery in patients undergoing VH, and the Quality of Recovery-15 questionnaire (QoR-15) was to be used for evaluation
Trial arms
Trial start
2024-05-20
Estimated PCD
2024-12-31
Trial end
2025-01-15
Status
Not yet recruiting
Treatment
duloxetine
In addition to our standard clinical protocol, study patients were administered 60 mg oral duloxetine 2 hours before surgery and 24 hours after surgery
Arms:
Duloxetine
Size
80
Primary endpoint
The primary outcome
8 hours after surgery
Eligibility criteria
Inclusion Criteria: * Patients undergoing VH with or without bilateral salpingo-oophorectomy to gynecologic conditions and uterine size ≤12 weeks * American Society of Anesthesiologists grade 1-3 Exclusion Criteria: * patients with chronic non-gynecologic conditions (liver or renal or pulmonary disease or diabetes) -those using psychiatric drugs (antidepressants, neuroleptics, lithium) in the last 1 year, --- * those with duloxetine allergy * those using opioids for gynecologic or non-gynecologic conditions * additional concurrent abdominal/ laparoscopic procedures * Total vaginal prolapsus
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}
Updated at
2024-05-28

1 organization

1 drug

2 indications