An interventional study of duloxetine in Vaginal Hysterectomy, Postoperative Pain and vNOTES, sponsored by Erzincan Military Hospital. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 20 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-22.
Sponsored by Erzincan Military Hospital · Not applicable, Interventional, and Prevention
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).
5,227 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.
This study's enrollment of 80 is close to the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Erzincan Military Hospital is the lead sponsor of 22 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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)
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
In addition to our standard clinical protocol, study patients were administered 60 mg oral duloxetine 2 hours before surgery and 24 hours after surgery
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.
Time frame: 8 hours after surgery
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
Time frame: on postoperative day 2
Ran from May 2024 to primary completion in Dec 2024, 7 months.
Of 1,888 non-industry interventional studies with no phase under Pain, Postoperative, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's 7 months is below that.
Counting every sponsor, half of 1,901 studies reached it within 11 months; a quarter within 6 and three quarters within 23.
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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Duloxetine
Erzincan Military Hospital