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

NCT06429605 | Completed

• 1 other identifier: Muğla-77
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• total QoR-15 score.

  on postoperative day 2

Study Arms (2)

Control

NO INTERVENTION

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

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

Drug: duloxetine

Interventions

duloxetine 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

Duloxetine

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Erzincan Military Hospital: lead

Study Sites (1)

Mugla Education and Research Hospital

Muğla, 35460, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD.

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 28, 2024
• Study Start: May 20, 2024
• Primary Completion: December 25, 2024
• Study Completion: December 27, 2024
• Last Updated: January 22, 2025

Record last verified: 2025-01

Locations

TU (1)