Effect of Paracervical Block on Postoperative Pain After vNOTES Uterosacral Ligament Suspension
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorErkan Gol
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Bupivacaine
DrugA 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.
Normal Saline
DrugA 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.
Treatment groups
58 Participants
are divided into 2 treatment groupsGroup A: Paracervical Block (Bupivacaine)Experimental treatment 1 intervention
Group B: Placebo (Normal Saline)Placebo comparator 1 intervention
Trial outcomes
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.
Time frame
6 hours after completion of surgery (assessed once at postoperative hour 6)Secondary outcomes
1
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)2
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)3
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)4
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 postoperativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
Erkan Gol
Lead sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor institution
Source ClinicalTrials.gov