An interventional study of Bupivacaine and Normal Saline in Pelvic Organ Prolapse (POP) and Postoperative Pain, sponsored by Erkan Gol. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-11.
Sponsored by Erkan Gol · Not applicable, Interventional, and Treatment
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.
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.
521 studies on the registry are indexed under Pelvic Organ Prolapse; 80 are open to participants now.
This study's planned enrollment of 58 is below the median of 80 across 336 interventional studies indexed under Pelvic Organ Prolapse.
Browse Pelvic Organ Prolapse studies →Erkan Gol is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive 10 mL of 0.5% bupivacaine administered as a paraservical injection during vNOTES uterosacral ligament suspension.
Drug: Bupivacaine
Participants will receive 10 mL of 0.9% normal saline administered as a paraservical injection during vNOTES uterosacral ligament suspension.
Drug: Normal Saline
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.
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
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.
Time frame: 6 hours after completion of surgery (assessed once at postoperative hour 6)
Postoperative Pain Scores Within 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.
Time frame: From completion of surgery through postoperative hour 24 (assessed at 0, 1, 2, 4, 12, and 24 hours)
Total Analgesic Consumption
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.
Time frame: From completion of surgery through postoperative hour 24 (cumulative dose assessed up to 24 hours)
Patient Satisfaction
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.
Time frame: 24 hours after completion of surgery (assessed once at postoperative hour 24)
Length of Hospital Stay
Duration of hospitalization measured in days from the date of surgery until discharge.
Time frame: From the date of surgery until hospital discharge, assessed up to 30 days postoperatively
Plan to share: Undecided
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Studies of the drug tested here: Bupivacaine
Erkan Gol