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New treatment option for Hysterotomy; Affecting Fetus
Official title Effect of Preventive Analgesia by Injection of a Local Anesthetic Before Vaginal Incision for Hysterectomy by vNOTES Approach
ClinicalTrials.gov ID: NCT05969457
What this study is testing
What is Naropeine?
Naropeine is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for hysterotomy; affecting fetus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70, women only
You may be able to join if
- 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...
- Person having read and understood the information letter and signed the consent form
- Person affiliated to a social security scheme
You likely can't join if
- Suspicion of malignant pathology
- History of rectal surgery
- History of pelvic inflammatory disease
- Suspicion of recto-vaginal endometriosis
- Virginity
- Contraindication to NAROPEINE 7.5 mg/mL, solution for injection in ampoule
See the full eligibility 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 read and understood the information letter and signed the consent form
- Person affiliated to a social security scheme
- Suspicion of malignant pathology
- History of rectal surgery
- History of pelvic inflammatory disease
- Suspicion of recto-vaginal endometriosis
- Virginity
- Contraindication to NAROPEINE 7.5 mg/mL, solution for injection in ampoule
- Contraindication to PROAMP SODIUM CHLORIDE 0.9%, solution for injection
- Patients on a low-salt diet
- History of more than 2 caesarean sections
- Estimated uterine size \> 700 g according to the following formula y = 0.35x + 107 (x = a × b × c), based on measurements taken on preoperative imaging (MRI or ultrasound). a=longitudinal diameter, b=sagital diameter...
- BMI \> 35
- Contraindication to analgesic molecules in intraoperative and postoperative protocols.
The study team makes the final eligibility decision.
Where it's taking place
- Le Havre, France
- Rouen, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Le Havre, France; Rouen, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.