Clincosm LogoSign in Get a demo

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

Sponsor
University Hospital, Rouen (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05969457
Collaborator
Groupe Hospitalier du Havre (Other)
108
Enrollment
2
Arms
48
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
108 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Supportive Care
Official Title:
Effect of Preventive Analgesia by Injection of a Local Anesthetic Before Vaginal Incision for Hysterectomy by vNOTES Approach: Randomized, Double-blind Study
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2027
Anticipated Study Completion Date :
Oct 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experienced group

Administration of Naropeine

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

Other: questionnaires
Numerical Rating scale Questionnaire FSFI Qustionnaire SF12 Questionnaire DN4
Placebo Comparator: Control group

Administration of a saline solution

Other: questionnaires
Numerical Rating scale Questionnaire FSFI Qustionnaire SF12 Questionnaire DN4

Other: Placebo
Injection of 20 mL of NaCl

Outcome Measures

Primary Outcome Measures

  1. pain after surgery [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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 read and understood the information letter and signed the consent form

  • Person affiliated to a social security scheme

Exclusion Criteria:

  • 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, c=transverse diameter.3

  • BMI > 35

  • Contraindication to analgesic molecules in intraoperative and postoperative protocols.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital, Rouen
  • Groupe Hospitalier du Havre

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT05969457
Other Study ID Numbers:
  • CHU de Rouen
First Posted:
Aug 1, 2023
Last Update Posted:
Aug 1, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Ropivacaine

Study Results

No Results Posted as of Aug 1, 2023