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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06429605
• Other study ID #: Mugla-77
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain
• Vaginal Hysterectomy

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