Идёт набор NCT07440576

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

Без фазы С лечением Pelvic Organ Prolapse (POP) Postoperative Pain

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Bupivacaine, Normal Saline.
Кому может быть актуально: Состояния в реестре: Pelvic Organ Prolapse (POP), Postoperative Pain. Базовые параметры: от 18 лет · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Turkey (Türkiye)
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

Препарат 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.
Препарат 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.

Первичные конечные точки

Postoperative Pain Score at 6 Hours [Срок оценки: 6 hours after completion of surgery (assessed once at postoperative hour 6)]

Вторичные конечные точки (4)

Postoperative Pain Scores Within 24 Hours [Срок оценки: From completion of surgery through postoperative hour 24 (assessed at 0, 1, 2, 4, 12, and 24 hours)]
Total Analgesic Consumption [Срок оценки: From completion of surgery through postoperative hour 24 (cumulative dose assessed up to 24 hours)]
Patient Satisfaction [Срок оценки: 24 hours after completion of surgery (assessed once at postoperative hour 24)]
Length of Hospital Stay [Срок оценки: From the date of surgery until hospital discharge, assessed up to 30 days postoperatively]

Критерии участия

Критерии включения

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