CompletedNot Applicable

Vaginal Cuff Bupivacaine Injection for Postoperative Pain

Turkey (Türkiye)48 participantsStarted 2025-08-05

Plain-language summary

This randomized controlled study evaluates whether injecting bupivacaine into the vaginal cuff during vaginal hysterectomy reduces postoperative pain. Vaginal hysterectomy is commonly performed for benign gynecologic conditions. Although it is associated with less pain compared to abdominal surgery, postoperative discomfort may still affect recovery and patient satisfaction. In this study, 48 women undergoing elective vaginal hysterectomy were randomly assigned to two groups. In the intervention group, 0.25% bupivacaine was injected bilaterally into the vaginal cuff after closure. In the control group, no local anesthetic injection was administered. All patients received the same standard postoperative pain management protocol. Pain levels were measured using the Visual Analog Scale (VAS) at 1, 3, 6, 12, and 24 hours after surgery. Additional analgesic consumption and possible complications were also recorded. The study aims to determine whether vaginal cuff bupivacaine infiltration improves early postoperative pain control.

Who can participate

Age range

35 Years – 75 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Women aged 35 to 75 years Scheduled for elective vaginal hysterectomy for benign gynecologic indications (e.g., uterine fibroids, adenomyosis, abnormal uterine bleeding, pelvic organ prolapse) Able to provide written informed consent Exclusion Criteria: Known or suspected gynecologic malignancy (endometrial, cervical, or uterine) Allergy or hypersensitivity to local anesthetics, especially bupivacaine Prior pelvic radiotherapy or major pelvic surgery resulting in altered anatomy Conditions preventing vaginal cuff injection (e.g., extensive scarring, active infection) Inability to reliably assess pain (e.g., impaired consciousness, dementia, severe psychiatric disorder) Refusal to sign informed consent

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Postoperative Pain Intensity Measured by Visual Analog Scale (VAS)

Timeframe: 1, 3, 6, 12, and 24 hours postoperatively

Postoperative Pain Intensity Measured by Visual Analog Scale (VAS)

Timeframe: 1, 3, 6, 12, and 24 hours postoperatively

Trial details

NCT IDNCT07426666

SponsorHavva Betül Bacak

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2025-10-24

View on ClinicalTrials.gov More Postoperative Pain Management trials