Effect of Paracervical Block on Postoperative Pain After vNOTES Uterosacral Ligament Suspension (vNOTES-PB)

March 9, 2026 updated by: Erkan Gol

A Prospective Randomized Double-Blind Placebo-Controlled Trial Evaluating the Effect of Paracervical Block on Postoperative Pain After vNOTES Uterosacral Ligament Suspension

This study is a prospective, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effect of paracervical block on early postoperative pain after vaginal natural orifice transluminal endoscopic surgery (vNOTES) uterosacral ligament suspension.

Eligible patients undergoing vNOTES uterosacral ligament suspension for benign gynecologic indications will be randomly assigned in a 1:1 ratio to receive either 10 mL of 0.5% bupivacaine or 10 mL of normal saline as a paracervical injection during surgery.

The primary outcome is postoperative pain assessed using the Visual Analog Scale (VAS) at 6 hours after surgery. Secondary outcomes include pain scores at multiple time points within 24 hours, total analgesic consumption, length of hospital stay, and patient satisfaction.

The study aims to determine whether paracervical block provides clinically meaningful pain reduction in the early postoperative period following vNOTES procedures.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Postoperative pain management remains an important component of enhanced recovery protocols in minimally invasive gynecologic surgery. Although vNOTES uterosacral ligament suspension is associated with reduced abdominal wall trauma, patients may still experience significant early postoperative pelvic pain. Paracervical block with local anesthetic agents has been proposed as a potential strategy to reduce early postoperative pain; however, high-quality randomized evidence in the context of vNOTES procedures is limited.

This single-center, prospective, randomized, double-blind, placebo-controlled trial will enroll 58 patients undergoing vNOTES uterosacral ligament suspension. Participants will be randomized using computer-generated permuted block randomization with allocation concealment ensured through sequentially numbered, opaque, sealed envelopes. During surgery, a blinded syringe containing either 0.5% bupivacaine or normal saline will be prepared by independent personnel and administered as a paracervical injection.

Postoperative pain will be evaluated using the Visual Analog Scale (VAS) at predefined time points (0, 1, 2, 4, 6, 12, and 24 hours). The primary endpoint is VAS score at 6 hours postoperatively. Secondary endpoints include total analgesic consumption within 24 hours, patient satisfaction, and perioperative recovery parameters. Statistical analyses will be conducted according to the intention-to-treat principle.

Study Type

Interventional

Enrollment (Estimated)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turkey (Türkiye), 34147
        • Recruiting
        • Bakirkoy Dr. Sadi Konuk Training and Research Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female patients aged 18 years or older
  • Symptomatic pelvic organ prolapse requiring uterosacral ligament suspension (USLS)
  • Planned hysterectomy (vaginal hysterectomy or vNOTES hysterectomy) with concomitant BS or BSO, followed by vNOTES uterosacral ligament suspension
  • ASA physical status I-III
  • Ability to provide written informed consent

Exclusion Criteria:

  • Known allergy or hypersensitivity to bupivacaine or local anesthetic agents
  • Chronic opioid use or chronic pain disorders
  • Previous pelvic radiation therapy
  • Severe hepatic or renal impairment
  • Coagulopathy or anticoagulant therapy contraindicating injection
  • Active pelvic infection
  • Pregnancy
  • Inability to understand the pain scoring system

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Paracervical Block (Bupivacaine)
Participants will receive 10 mL of 0.5% bupivacaine administered as a paraservical injection during vNOTES uterosacral ligament suspension.
Drug: Bupivacaine
A total of 10 mL of 0.5% bupivacaine will be administered as a paraservical injection during vNOTES uterosacral ligament suspension. The solution will be prepared in identical syringes by independent personnel to maintain blinding.
Placebo Comparator: Placebo (Normal Saline)
Participants will receive 10 mL of 0.9% normal saline administered as a paraservical injection during vNOTES uterosacral ligament suspension.
Drug: Normal Saline
A total of 10 mL of 0.9% normal saline will be administered as a paraservical injection during vNOTES uterosacral ligament suspension. The solution will be prepared in identical syringes to ensure blinding.
Other Names:
  • 0.9% Sodium Chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain Score at 6 Hours
Time Frame: 6 hours after completion of surgery (assessed once at postoperative hour 6)
Postoperative pain intensity assessed using a 10-cm Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores represent greater pain intensity.
6 hours after completion of surgery (assessed once at postoperative hour 6)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Hospital Stay
Time Frame: From the date of surgery until hospital discharge, assessed up to 30 days postoperatively
Duration of hospitalization measured in days from the date of surgery until discharge.
From the date of surgery until hospital discharge, assessed up to 30 days postoperatively
Postoperative Pain Scores Within 24 Hours
Time Frame: From completion of surgery through postoperative hour 24 (assessed at 0, 1, 2, 4, 12, and 24 hours)
Postoperative pain intensity assessed using a 10-cm Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain). Pain scores will be recorded at postoperative hours 0 (upon arrival in recovery room), 1, 2, 4, 12, and 24.
From completion of surgery through postoperative hour 24 (assessed at 0, 1, 2, 4, 12, and 24 hours)
Total Analgesic Consumption
Time Frame: From completion of surgery through postoperative hour 24 (cumulative dose assessed up to 24 hours)
Total cumulative dose of rescue analgesic medication administered postoperatively, recorded in milligrams (mg) and converted to morphine-equivalent dose when applicable. Higher values indicate greater analgesic requirement.
From completion of surgery through postoperative hour 24 (cumulative dose assessed up to 24 hours)
Patient Satisfaction
Time Frame: 24 hours after completion of surgery (assessed once at postoperative hour 24)
Patient-reported satisfaction with postoperative pain control assessed using a 10-point Numeric Rating Scale (0 = not satisfied at all; 10 = completely satisfied). Higher scores represent greater satisfaction.
24 hours after completion of surgery (assessed once at postoperative hour 24)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erkan Gol

Investigators

  • Principal Investigator: Erkan Göl, MD, Bakırköy Dr. Sadi Konuk Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

February 12, 2026

First Submitted That Met QC Criteria

February 26, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-04-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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