Hysterotomy; Affecting FetusPhase 3ANOTESNCT05969457
Effect of Preventive Analgesia by Injection of a Local Anesthetic Before Vaginal Incision for Hysterectomy by vNOTES Approach
A Phase 3 study testing Naropeine and questionnaires in people with Hysterotomy; Affecting Fetus, run by University Hospital, Rouen at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Hysterotomy; Affecting Fetus
- What is being tested?
- Naropeine and questionnaires
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 2 sitesFrance
- Study dates
- 16 Sep 2025to 1 Sep 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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, c=transverse diameter.3
- BMI > 35
- Contraindication to analgesic molecules in intraoperative and postoperative protocols.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Gh Le Havre
Le Havre, 76083
Anthony Feraille, Dr, 02 32 73 32 32, Anthony.feraille@ch-havre.fr
Anthony Feraille, Dr
- Recruiting
Chu Rouen
Rouen, 76031
Patrice Crochet, Dr, 06 88 38 48 03 ext. +33, Patrice.Crochet@chu-rouen.fr
Morgane Perrin, Dr
About this study
Official title: Effect of Preventive Analgesia by Injection of a Local Anesthetic Before Vaginal Incision for Hysterectomy by vNOTES Approach: Randomized, Double-blind Study
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
- Being tested
- Naropeine, questionnaires, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaropeineDrug
Local anesthesia with injection of Ropivacaine (20mL of ropivacaine 7.5 mg/mL, i.e. 150mg)
questionnairesOther
Numerical Rating scale Questionnaire FSFI Qustionnaire SF12 Questionnaire DN4
PlaceboOther
Injection of 20 mL of NaCl
| Study group | Role | What they receive |
|---|---|---|
| Experienced group | Experimental | Administration of Naropeine Receives: Drug: Naropeine; Other: questionnaires |
| Control group | Placebo comparator | Administration of a saline solution Receives: Other: questionnaires; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain after surgery
Pain will be assessed by the post-operative hospital nurse using a numerical rating scale (NRS) NRS score from 1 to 10 -> 10 correspoding to the worst pain
Measured: 4hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start16 Sep 2025
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hysterotomy; Affecting FetusStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Collaborators
- Groupe Hospitalier du Havre
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05969457
- Sponsor's protocol ID
- 2022/0270/HP
- Acronym
- ANOTES
- Status last verified
- Feb 2026
- First submitted
- 17 Jul 2023
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preventive Analgesia by Injection of a Local Anesthetic Before Vaginal Incision for Hysterectomy by vNOTES Approach: Randomized, Double-blind Study
- ClinicalTrials.gov ID
- NCT05969457
- Acronym / sponsor ID
- ANOTES / 2022/0270/HP
- Conditions
- Hysterotomy; Affecting Fetus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Collaborators
- Groupe Hospitalier du Havre
- Study start
- 16 Sep 2025 (actual)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experienced group | Experimental | Drug: Naropeine, Other: questionnairesAdministration of Naropeine |
| Control group | Placebo comparator | Other: questionnaires, Other: PlaceboAdministration of a saline solution |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- Suspicion of malignant pathology
- History of rectal surgery
- History of pelvic inflammatory disease
- Suspicion of recto-vaginal endometriosis
- Virginity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NaropeineLocal anesthesia with injection of Ropivacaine (20mL of ropivacaine 7.5 mg/mL, i.e. 150mg) | Drug | Experienced group |
| questionnairesNumerical Rating scale Questionnaire FSFI Qustionnaire SF12 Questionnaire DN4 | Other | Control group, Experienced group |
| PlaceboInjection of 20 mL of NaCl | Other | Control group |
Primary outcome
pain after surgery
Time frame: 4hours after surgery
Pain will be assessed by the post-operative hospital nurse using a numerical rating scale (NRS) NRS score from 1 to 10 -> 10 correspoding to the worst pain
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Naropeine and questionnaires in people with Hysterotomy; Affecting Fetus, run by University Hospital, Rouen at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrice Crochet, Dr (06 88 38 48 03 ext. +33, Patrice.Crochet@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain after surgery (time frame: 4hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.