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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorUniversity Hospital, Rouen

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 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Suspicion of malignant pathology

History of rectal surgery

History of pelvic inflammatory disease

Suspicion of recto-vaginal endometriosis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Naropeine

    Drug

    Local anesthesia with injection of Ropivacaine (20mL of ropivacaine 7.5 mg/mL, i.e. 150mg)

  • questionnaires

    Other intervention

    Numerical Rating scale Questionnaire FSFI Qustionnaire SF12 Questionnaire DN4

  • Placebo

    Other intervention

    Injection of 20 mL of NaCl

Treatment groups

108 Participants
are divided into 2 treatment groups
Group A: Experienced groupExperimental treatment 2 interventions
Group B: Control groupPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
4hours after surgery

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Rouen

Lead sponsor

Groupe Hospitalier du Havre

Collaborator