Reduction in Pain Within 24 Hours of Surgery
Conditions
Keywords
excision, Reconstructive surgery of the clitoris, sexual health, chronic pain,, The pudendal block nerve endings., postoperative pain in clitoral surgery
Brief summary
Reconstructive surgery of the clitoris is part of the care offered during a process of care of women victims of MSF. It consists in reconstituting a clitoral neogland after removal of the vulvar excisional scar and recovery of the remaining clitoris. Studies that have monitoring the implementation of this surgery show that it improves the well-being of the patients, brings benefits anatomically, sexual health, personal development, and in the long term decreases chronic pain. Currently the standard method used in the usual care of the patient is: general anesthesia with an intravenous analgesic protocol then oral without anesthesia regional loco The pudendal block that the investigators want to evaluate in this research, is a technique that has made proven in several types of surgery, associated with very few complications and easily reproducible.
Detailed description
Reconstructive surgery of the clitoris is part of the care offered during a process of care of women victims of MSF. It consists in reconstituting a clitoral neogland after removal of the vulvar excisional scar and recovery of the remaining clitoris. Studies that have monitoring the implementation of this surgery show that it improves the well-being of the patients, brings benefits anatomically, sexual health, personal development, and in the long term decreases chronic pain. Currently the standard method used in the usual care of the patient is: general anesthesia with an intravenous analgesic protocol then oral without anesthesia regional loco The pudendal block that the investigators want to evaluate in this research, is a technique that has made proven in several types of surgery, associated with very few complications and easily reproducible. The human clitoris is the most sensitive organ in the human body, with over 8000 endings nervous. All these endings come from the pudendal nerve, itself most often of nerve roots S3. The main hypothesis is that a bilateral anesthetic block of this nerve would reduce postoperative pain in clitoral surgery
Interventions
PROCEDUREpudendal block
general anesthesia with an intravenous analgesic protocol then oral without anesthesia regional loco
Sponsors
Raincy Montfermeil Hospital Group
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Prospective non-randomized study comparing the group of patients who received general anesthesia and pudendal block in a historical cohort of patients treated by the standard establishment protocol, that is to say under general anesthesia without locoregional anesthesia.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Major patient, * With the indication of a clitoral repair surgery * Having expressed their free and informed written consent * Affiliated with a social security scheme
Exclusion criteria
\- Contraindication to the pudendal block technique: notably : * blood crass disorder * allergy to Naropein * infection at the injection site - Poor understanding of the interest of the practice proposed experimental
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| decrease in the mean of the self-reported pain scores in the first 24 hours | 24 hours | decrease in the mean of the self-reported pain scores in the first 24 hours using a Numerical visual scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| decrease in pain on the EVN at 2 hours, 6 hours , Day 1 and Day 7 postoperative | 2 hours, 6 hours, Day 1 and Day 7 postoperative | decrease in pain on the EVN at 2 hours, 6 hours , Day 1 and Day 7 with the pudental block method |
Countries
France
Contacts
Primary ContactMathieux CAMBY, MD
Backup ContactSarah ABRAMOWICZ, MD
Outcome results
None listed