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| Name | Class |
|---|---|
| Groupe Hospitalier du Havre | OTHER |
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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:
In both groups, systematic intraoperative and postoperative analgesia will be identical.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experienced group | Experimental | Administration of Naropeine |
|
| Control group | Placebo Comparator | Administration of a saline solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naropeine | Drug | Local anesthesia with injection of Ropivacaine (20mL of ropivacaine 7.5 mg/mL, i.e. 150mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Women
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrice Crochet, Dr | Contact | 06 88 38 48 03 | +33 | Patrice.Crochet@chu-rouen.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gh Le Havre | Recruiting | Le Havre | 76083 | France |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| questionnaires | Other | Numerical Rating scale Questionnaire FSFI Qustionnaire SF12 Questionnaire DN4 |
|
| Placebo | Other | Injection of 20 mL of NaCl |
|
| Chu Rouen | Recruiting | Rouen | 76031 | France |
|
| D000588 |
| Amines |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |