Pelvic Organ Prolapse (POP), Postoperative Pain
Conditions
Keywords
vnotes, uterosacral ligament suspension, paracervical block, bupivacaine, minimally invasive surgery, enhanced recovery
Brief summary
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
DRUGBupivacaine
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.
DRUGNormal 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.
Sponsors
Erkan Gol
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants, care providers, investigators, and outcome assessors will be blinded to group allocation. Study solutions (0.5% bupivacaine or normal saline) will be prepared in identical syringes by independent personnel not involved in postoperative assessment. Allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes.
Intervention model description
Participants will be randomized in a 1:1 ratio to receive either paracervical block with 0.5% bupivacaine or a placebo (normal saline) during vNOTES uterosacral ligament suspension.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Score at 6 Hours | 6 hours after completion of surgery (assessed once at postoperative hour 6) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Scores Within 24 Hours | From completion of surgery through postoperative hour 24 (assessed at 0, 1, 2, 4, 12, and 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. |
| Total Analgesic Consumption | From completion of surgery through postoperative hour 24 (cumulative dose assessed up to 24 hours) | 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. |
| Patient Satisfaction | 24 hours after completion of surgery (assessed once at postoperative hour 24) | 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. |
| Length of Hospital Stay | From the date of surgery until hospital discharge, assessed up to 30 days postoperatively | Duration of hospitalization measured in days from the date of surgery until discharge. |
Countries
Turkey (Türkiye)
Contacts
CONTACTErkan Göl, MD
CONTACTKeziban Doğan, Professor
PRINCIPAL_INVESTIGATORErkan Göl, MD
Bakırkoy Dr. Sadi Konuk Training and Research Hospital
Outcome results
None listed