NCT05969457

Effect of Preventive Analgesia by Injection of a Local Anesthetic Before Vaginal Incision for Hysterectomy by vNOTES Approach

Effect of Preventive Analgesia by Injection of a Local Anesthetic Before Vaginal Incision for Hysterectomy by vNOTES Approach: Randomized, Double-blind Study

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: University Hospital, Rouen · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The research procedure is the injection of 20 mL of Ropivacaine solution (vs. saline) to create a paracervical block at the beginning of surgery, while the patient is already under general anesthesia. This injection will take place 3 minutes before the vaginal incision, via 4 injection points. Injections are made 3 mm deep into the vaginal cul de sac. Randomization takes place before surgery by vNOTES: * Experienced group: Local anesthesia with injection of Ropivacaine (20mL of ropivacaine 7.5 mg/mL, i.e. 150mg) and general anesthesia * Control group: Injection of 20mL of placebo (saline) and general anesthesia In both groups, systematic intraoperative and postoperative analgesia will be identical.

Conditions

• Hysterotomy; Affecting Fetus

Interventions

Type	Name	Description
DRUG	Naropeine	Local anesthesia with injection of Ropivacaine (20mL of ropivacaine 7.5 mg/mL, i.e. 150mg)
OTHER	questionnaires	Numerical Rating scale Questionnaire FSFI Qustionnaire SF12 Questionnaire DN4
OTHER	Placebo	Injection of 20 mL of NaCl

Timeline

• Start date: 2024-05-30
• Primary completion: 2027-10-01
• Completion: 2027-10-01
• First posted: 2023-08-01
• Last updated: 2024-04-01