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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06429605
Other study ID # Mugla-77
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 20, 2024
Est. completion date January 15, 2025

Study information

Verified date May 2024
Source Erzincan Military Hospital
Contact Kemal Güngördük
Phone 05057465266
Email drkemalgungorduk@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date January 15, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 75 Years
Eligibility 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

Study Design


Intervention

Drug:
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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Erzincan Military Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary The primary outcome the level of abdominal pain during ambulation (according to VAS score) Since the visual analog scale (VAS) has been used in prior studies for evaluating similar outcomes [10], a 100-mm VAS was used to grade the level of pain. For assessing pain at rest, patients were asked to grade their level of pain from 0 (no pain) to 10 (worst pain ever experienced) at the abdomen and at the vagina while lying in bed. For assessing pain during ambulation, patients were asked to stand up, walk a few steps, and sit in a chair. Then, they were asked to grade their pain, using the same scale, during ambulation. 8 hours after surgery
Secondary total QoR-15 score. The QoR-15 is a 15-item questionnaire that measures the patient's QoR. Each item is answered on an 11-point numerical rating scale. The score ranges from 0 to 150 with a higher score indicating a better QoR. It measures in the domains of pain, physical comfort, physical independence, psychological support, and emotional state on postoperative day 2
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