Vaginal Cuff Bupivacaine Injection for Postoperative Pain

NCT07426666 | Completed

• 1 other identifier: gopvahmarcaine
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Pain Management

Keywords

Vaginal Hysterectomy; Bupivacaine; Analgesia

Outcome Measures

Primary Outcomes (2)

• Postoperative Pain Intensity Measured by Visual Analog Scale (VAS)

  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

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

• Postoperative Pain Intensity Measured by Visual Analog Scale (VAS)

  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.

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

Study Arms (2)

Bupivacaine Injection Group

EXPERIMENTAL

Participants in this group underwent standard vaginal hysterectomy. After vaginal cuff closure, bilateral infiltration of 10 mL 0.25% bupivacaine was administered to the lateral aspects of the vaginal cuff. All patients received the standard postoperative analgesia protocol.

Drug: Bupivacaine %0.25 (isobaric)

Control Group

NO INTERVENTION

Participants in this group underwent standard vaginal hysterectomy without local anesthetic infiltration of the vaginal cuff. All patients received the same standard postoperative analgesia protocol.

Interventions

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.

Bupivacaine Injection Group

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Havva Betül Bacak: lead

Study Sites (1)

SBÜ Gaziosmanpaşa Training and Research Hospital

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

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single-blind study. Participants were blinded to group allocation. The surgeon and clinical staff were aware of the treatment assignment due to the nature of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: md

Model Details: Participants were randomly assigned in a 1:1 ratio to one of two parallel groups using a sealed-envelope method. The intervention group received bilateral vaginal cuff infiltration with 10 mL of 0.25% bupivacaine after cuff closure, while the control group underwent the same surgical procedure without local anesthetic infiltration. The study was conducted as a single-center, open-label randomized controlled trial.

Study Record Dates

• First Submitted: February 15, 2026
• First Posted: February 23, 2026
• Study Start: August 5, 2025
• Primary Completion: October 24, 2025
• Study Completion: October 24, 2025
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)