Effect of Paracervical Block on Postoperative Pain After vNOTES Uterosacral Ligament Suspension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bupivacaine, Normal Saline.
- Who it may be relevant to
- Registry conditions: Pelvic Organ Prolapse (POP), Postoperative Pain. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Randomized Double-Blind Placebo-Controlled Trial Evaluating the Effect of Paracervical Block on Postoperative Pain After vNOTES Uterosacral Ligament Suspension
Overview
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.
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.
Interventions
- 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. - 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.
Primary outcome measures
- Postoperative Pain Score at 6 Hours [Time frame: 6 hours after completion of surgery (assessed once at postoperative hour 6)]
Secondary outcome measures (4)
- 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)]
- Total Analgesic Consumption [Time frame: 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)]
- Length of Hospital Stay [Time frame: From the date of surgery until hospital discharge, assessed up to 30 days postoperatively]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Bakirkoy Dr. Sadi Konuk Training and Research Hospital — Istanbul
Identifiers
NCT: NCT07440576 · 2026-04-05