Clinical Trial: Postoperative pain reduction with Epinephrine And Ropivacaine paracervical bLock in vNOTES hysterectomy: the PEARL randomized controlled trial (Japan)

Tokyo, Oct. 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063239) titled 'Postoperative pain reduction with Epinephrine And Ropivacaine paracervical bLock in vNOTES hysterectomy: the PEARL randomized controlled trial' on Oct. 10.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Active

Primary Sponsor: Institute - Sendai City Hospital

Condition: Condition - Patients undergoing elective vNOTES hysterectomy for benign gynecological conditions Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To determine whether paracervical block with ropivacaine plus epinephrine before the vaginal phase of vNOTES hysterectomy reduces early postoperative pain compared with paracervical injection of epinephrine alone. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Ropivacaine-epinephrine group (RE group): Before the vaginal phase of vNOTES hysterectomy, bilateral paracervical block is performed with 20 mL of solution containing 0.75% ropivacaine 10 mL (75 mg), epinephrine 100 micrograms and normal saline (final concentrations: ropivacaine 0.375%, epinephrine 1:200,000). Four mL is injected at each of five sites at the cervicovaginal junction (3 and 9 o'clock, bilateral uterosacral ligament bases, and 12 o'clock) after aspiration. Interventions/Control_2 - Epinephrine-alone group (E group): Using the same timing, sites, depth and volume per site, 20 mL of epinephrine 100 micrograms diluted with normal saline (1:200,000) is injected paracervically, as routinely performed for hemostasis at our institution.

Eligibility: Age-lower limit - 18 years-old 2. Patients scheduled for vNOTES hysterectomy for benign gynecologic disease3. Patients undergoing surgery under general anesthesia4. Patients able to rate pain on the NRS5. Patients who provide written informed consent of their own free will after receiving a full explanation of the study Key exclusion criteria - 1. History of hypersensitivity to ropivacaine or amide-type local anesthetics2. Patients for whom epinephrine is judged inappropriate3. Severe cardiovascular disease or severe hepatic or renal dysfunction4. Chronic opioid use5. Preoperative analgesic use or other conditions judged likely to substantially affect the primary outcome6. Pregnancy or possible pregnancy7. Surgery for malignant disease8. Any other patient judged ineligible by the principal investigator Target Size - 80

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 09 Month 25 Day Date of IRB - 2026 Year 10 Month 06 Day Anticipated trial start date - 2026 Year 10 Month 13 Day Last follow-up date - 2027 Year 10 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072384

Disclaimer: Curated by HT Syndication.