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

Hysterotomy; Affecting Fetus Clinical Trial

— ANOTES  

Official title:

Effect of Preventive Analgesia by Injection of a Local Anesthetic Before Vaginal Incision for Hysterectomy by vNOTES Approach: Randomized, Double-blind Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05969457
• Other study ID #: CHU de Rouen
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 30, 2024
• Est. completion date: October 1, 2027

Study information

• Verified date: March 2024
• Source: University Hospital, Rouen
• Contact: David Mallet
• Phone: 02 32 88 82 65
• Email: secretariat.DRC[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 108
• Est. completion date: October 1, 2027
• Est. primary completion date: October 1, 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hysterotomy; Affecting Fetus

Intervention

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
Injection of 20 mL of NaCl

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Rouen	Groupe Hospitalier du Havre

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4hours after surgery