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Completed

NCT Number: NCT07426666

Vaginal Cuff Bupivacaine Injection for Postoperative Pain

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.

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Key information

Age range

35 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

SBÜ Gaziosmanpaşa Training and Research Hospital

Istanbul, Outside of the US, 33400, Turkey (Türkiye)

About this study

This prospective, single-center, randomized controlled trial was conducted to evaluate the effect of bilateral vaginal cuff infiltration with 0.25% bupivacaine on postoperative pain following vaginal hysterectomy performed for benign gynecologic indications.

Vaginal hysterectomy, although minimally invasive, may still be associated with significant postoperative discomfort. The uterus and surrounding structures receive innervation from the uterosacral plexus (Lee-Frankenhauser plexus), which plays a role in postoperative pain transmission. Local anesthetic infiltration targeting this anatomical region may reduce nociceptive signaling and improve early postoperative pain control.

A total of 48 women aged 35-75 years scheduled for elective vaginal hysterectomy were randomized using a sealed-envelope method into two parallel groups:

Intervention group (n=24): Bilateral infiltration of 10 mL 0.25% bupivacaine into the lateral aspects of the vaginal cuff following cuff closure.

Control group (n=24): Standard surgical procedure without local anesthetic infiltration.

All procedures were performed under general anesthesia. Postoperative analgesia was administered according to institutional standard protocol. Pain intensity was assessed using the Visual Analog Scale (VAS) at postoperative 1, 3, 6, 12, and 24 hours.

The primary outcome was postoperative pain intensity measured by VAS scores. Secondary outcomes included total analgesic consumption within the first 24 hours, intraoperative and postoperative complications, and length of hospital stay.

The study was completed after enrollment of 40 participants, and outcomes were analyzed to determine the efficacy and safety of vaginal cuff bupivacaine infiltration in reducing early postoperative pain following vaginal hysterectomy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine %0.25 (isobaric)

Drug

0.25% bupivacaine (10 mL) was bilaterally infiltrated into the lateral aspects of the vaginal cuff following cuff closure during vaginal hysterectomy.

Primary outcomes

  1. Postoperative Pain Intensity Measured by Visual Analog Scale (VAS)

    Time frame: 1, 3, 6, 12, and 24 hours postoperatively

    Pain intensity was assessed using a 10-point Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Scores were recorded at predefined postoperative time points to evaluate the effectiveness of vaginal cuff bupivacaine infiltration

  2. Postoperative Pain Intensity Measured by Visual Analog Scale (VAS)

    Time frame: 1, 3, 6, 12, and 24 hours postoperatively

    Pain intensity was assessed using a 10-point Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Scores were recorded at predefined postoperative time points to evaluate the effectiveness of vaginal cuff bupivacaine infiltration.

Sponsors and collaborators

Lead sponsor

Havva Betül Bacak

Other Gov

Registry information

Official study title

The Effect of Vaginal Cuff Bupivacaine Injection on Postoperative Pain After Vaginal Hysterectomy

Acronym: marcaine

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 23, 2026
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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