Ropivacaine Injection for Hysterectomy Pain Management
Effect of Preventive Analgesia by Injection of a Local Anesthetic Before Vaginal Incision for Hysterectomy by vNOTES Approach
Recruiting
Phase 3
Interventional Study
Hysterotomy; Affecting Fetus
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 70
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Supportive Care
- Participants needed
- 108 (estimated)
- Sponsor
- University Hospital, Rouen · Other
Who this trial is looking for
This trial is looking for women aged 18 to 70 who are scheduled for a specific type of hysterectomy called vNOTES. Participants will receive an injection of local anesthesia before surgery to help manage pain.
Are You a Good Fit for This Trial?
You may be able to join if
- I am between 18 and 70 years old.
- I am scheduled for vNOTES surgery for a total hysterectomy.
- I have a benign condition requiring surgery.
- I have read and understood the trial information.
- I have signed the consent form.
- I am covered by a social security scheme.
You may not be able to join if
- I have a suspected malignant condition.
- I have a history of rectal surgery.
- I have had pelvic inflammatory disease.
- I have a suspected case of recto-vaginal endometriosis.
- I am a virgin.
- I cannot take Ropivacaine.
- I cannot take saline solution.
- My BMI is over 35.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Adult patients aged 18 to 70 inclusive
* Patient scheduled for vNOTES surgery for total hysterectomy for benign pathology, whether or not associated with an adnexal procedure (unilateral or bilateral salpingectomy or adnexectomy (for cysts smaller than 6 cm)).
* Person having …
Contacts