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New treatment option for Pelvic Organ Prolapse (POP)
Official title Effect of Paracervical Block on Postoperative Pain After vNOTES Uterosacral Ligament Suspension
ClinicalTrials.gov ID: NCT07440576
What this study is testing
What is Bupivacaine?
Bupivacaine is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for pelvic organ prolapse (pop).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join 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 likely can't join 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Istanbul, Istanbul, Turkey (Türkiye)
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Istanbul, Istanbul, Turkey (Türkiye). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.