Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-25 @ 4:24 PM
Study NCT ID:
NCT05969457
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-01
First Post:
2023-07-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Preventive Analgesia by Injection of a Local Anesthetic Before Vaginal Incision for Hysterectomy by vNOTES Approach
Sponsor:
University Hospital, Rouen
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ANOTES
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: