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

Erzincan Military Hospital

Status: Completed

Conditions: Postoperative Pain; Vaginal Hysterectomy; vNOTES

Treatments: Drug: duloxetine

Study type: Interventional

Funder types: Other

Identifiers

NCT06429605

Muğla-77

Details and patient eligibility

About

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).

Enrollment: 80 patients

Sex: Female

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Control

No Intervention group

Description:

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)

Duloxetine

Experimental group

Description:

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

Treatment:

Drug: duloxetine