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

NCT ID: NCT06429605

Last Updated: 2025-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-20
• Study Completion Date: 2024-12-27

Brief Summary

Hysterectomy performed through the vaginal route (HVR) is the preferred method for women seeking hysterectomy to address uterine concerns such as premalignant conditions and fibroids. Compared to abdominal or laparoscopic approaches, HVR has shown to lead to quicker recovery times and faster resumption of daily activities. However, effectively managing postoperative pain remains a significant challenge for HVR patients.

Duloxetine, a serotonin-norepinephrine reuptake inhibitor typically prescribed for major depression and anxiety, has also been utilized in treating chronic pain conditions like osteoarthritis and musculoskeletal pain. However, research into its use for alleviating acute postoperative pain is currently limited to a single trial. Additionally, it's unclear whether perioperative duloxetine could enhance overall recovery quality after surgery. This study hypothesized that perioperative duloxetine could improve postoperative recovery for HVR patients, with evaluation using the Quality of Recovery-15 questionnaire (QoR-15).

Conditions

Vaginal Hysterectomy; Postoperative Pain; vNOTES

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Control

Only our clinic's standard preoperative and postoperative care were used (Güngördük K, Selimoğlu B, Gülseren V, Yasar E, Comba C, Özdemir İA. Effect of abdominal hot pack application on gastrointestinal motility recovery after comprehensive gynecologic staging surgery. Int J Gynaecol Obstet. 2024 Mar;164(3):1108-1116)

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

duloxetine

Intervention Type: DRUG

In addition to our standard clinical protocol, study patients were administered 60 mg oral duloxetine 2 hours before surgery and 24 hours after surgery

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients undergoing HVR ( vaginal natural orifice transluminal endoscopic surgery) hysterectomy and salpingectomy, with the option of additional procedures such as oophorectomy, uterosacral ligament plications, trans obturator tape insertion, colporrhaphy, or sentinel lymphadenectomy
• American Society of Anesthesiologists grade 1-3

Exclusion Criteria

• patients with chronic non-gynecologic conditions (liver-renal or pulmonary disease)
• 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 procedures
• Total vaginal prolapsus (POPQ 4)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Erzincan Military Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kemal GUNGORDUK

MD.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mugla Education and Research Hospital

Muğla, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Muğla-77

Identifier Type: -

Identifier Source: org_study_id