Effect of Paracervical Block on Postoperative Pain After vNOTES Uterosacral Ligament Suspension

NCT07440576 | Recruiting

• 1 other identifier: 2026-04-05
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pelvic Organ Prolapse (POP); Postoperative Pain

Keywords

vnotes; uterosacral ligament suspension; paracervical block; bupivacaine; minimally invasive surgery; enhanced recovery

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Score at 6 Hours

  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 Outcomes (4)

• Postoperative Pain Scores Within 24 Hours

  From completion of surgery through postoperative hour 24 (assessed at 0, 1, 2, 4, 12, and 24 hours)

• Total Analgesic Consumption

  From completion of surgery through postoperative hour 24 (cumulative dose assessed up to 24 hours)

• Patient Satisfaction

  24 hours after completion of surgery (assessed once at postoperative hour 24)

• Length of Hospital Stay

  From the date of surgery until hospital discharge, assessed up to 30 days postoperatively

Study Arms (2)

Paracervical Block (Bupivacaine)

EXPERIMENTAL

Participants will receive 10 mL of 0.5% bupivacaine administered as a paraservical injection during vNOTES uterosacral ligament suspension.

Drug: Bupivacaine

Placebo (Normal Saline)

PLACEBO COMPARATOR

Participants will receive 10 mL of 0.9% normal saline administered as a paraservical injection during vNOTES uterosacral ligament suspension.

Drug: Normal Saline

Interventions

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.

Paracervical Block (Bupivacaine)

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.

Also known as: 0.9% Sodium Chloride

Placebo (Normal Saline)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erkan Gol: lead

Study Sites (1)

Bakirkoy Dr. Sadi Konuk Training and Research Hospital

Istanbul, Istanbul, 34147, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pelvic Organ Prolapse; Pain, Postoperative

Interventions

Bupivacaine; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Erkan Göl, MD

  Bakirkoy Dr. Sadi Konuk Research and Training Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erkan Göl, MD

CONTACT

+905398517917; drerkangol@gmail.com

Keziban Doğan, Professor

CONTACT

+905356336207; drkzbn70@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, care providers, investigators, and outcome assessors will be blinded to group allocation. Study solutions (0.5% bupivacaine or normal saline) will be prepared in identical syringes by independent personnel not involved in postoperative assessment. Allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomized in a 1:1 ratio to receive either paracervical block with 0.5% bupivacaine or a placebo (normal saline) during vNOTES uterosacral ligament suspension.

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 27, 2026
• Study Start: March 9, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

TU (1)