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NCT Number: NCT07440576

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.

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Key information

Conditions

Pelvic Organ Prolapse (POP) Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Postoperative Complications Postoperative Pain Prolapse Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Bupivacaine

Drug

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.

normal saline

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Erkan Göl, MD

CONTACT

[email protected]

+905398517917

Keziban Doğan, Professor

CONTACT

[email protected]

+905356336207

Sponsors and collaborators

Lead sponsor

Erkan Gol

Other Gov

Registry information

Official study title

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

Acronym: vNOTES-PB

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 27, 2026
Registry last updated
Mar 11, 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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