Vaginal Cuff Bupivacaine Injection for Postoperative Pain (marcaine)

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain Management
• Intervention / Treatment: Drug: Bupivacaine %0.25 (isobaric)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Outside of the US
    • Istanbul, Outside of the US, Turkey (Türkiye), 33400
      • SBÜ Gaziosmanpaşa Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bupivacaine Injection Group; 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); 0.25% bupivacaine (10 mL) was bilaterally infiltrated into the lateral aspects of the vaginal cuff following cuff closure during vaginal hysterectomy.
No Intervention: Control Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Havva Betül Bacak

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2025
• Primary Completion (Actual): October 24, 2025
• Study Completion (Actual): October 24, 2025

Study Registration Dates

• First Submitted: February 15, 2026
• First Submitted That Met QC Criteria: February 15, 2026
• First Posted (Actual): February 23, 2026

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 15, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Analgesia; Bupivacaine; Vaginal Hysterectomy
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Agnosia
• Other Study ID Numbers: gopvahmarcaine

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No