Reduction in Pain Within 24 Hours of SurgeryDORECLINCT05058248
Evaluation of a Locoregional Anesthesia Protocol by Pudendal Block in Reconstructive Surgery Clitoral
A study testing pudendal block in people with Reduction in Pain Within 24 Hours of Surgery, run by Raincy Montfermeil Hospital Group at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Reduction in Pain Within 24 Hours of Surgery
- What is being tested?
- pudendal block
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteFrance
- Study dates
- 14 Oct 2021to Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major patient,
- With the indication of a clitoral repair surgery
- Having expressed their free and informed written consent
- Affiliated with a social security scheme
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Camby
Montreuil, 93100
Mathieu CAMBY, mathieu.camby@ght-gpne.fr
About this study
Official title: "Evaluation of a Locoregional Anesthesia Protocol by Pudendal Block in Reconstructive Surgery Clitoral " Pudendal Block in Clitoral Surgery (Pain REparation CLItoris)
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.
Read the 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
- Being tested
- pudendal block
- Keywords
- excision, Reconstructive surgery of the clitoris, sexual health, chronic pain,, The pudendal block nerve endings., postoperative pain in clitoral surgery
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pudendal blockProcedure or surgery
Also called standard method
general anesthesia with an intravenous analgesic protocol then oral without anesthesia regional loco
| Study group | Role | What they receive |
|---|---|---|
| Pudendal block | Active comparator | Ultrasound-guided bilateral pudendal block at the start of surgery, in gynecological position: injection of 15 mL of 0.475% Naropein in each ischiorectal fossa. Receives: Procedure: pudendal block |
| the standard method | Other | Operated and anesthetized patients according to the standard method within the department Receives: Procedure: pudendal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
decrease in the mean of the self-reported pain scores in the first 24 hours
decrease in the mean of the self-reported pain scores in the first 24 hours using a Numerical visual scale
Measured: 24 hours
Secondary outcomes (1)
decrease in pain on the EVN at 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
Measured: 2 hours, 6 hours, Day 1 and Day 7 postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start14 Oct 2021
- Primary completionJan 2023 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reduction in Pain Within 24 Hours of SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Raincy Montfermeil Hospital Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05058248
- Sponsor's protocol ID
- CHIM -RIPH2-001
- Acronym
- DORECLI
- Status last verified
- Sep 2021
- First submitted
- 13 Sep 2021
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Evaluation of a Locoregional Anesthesia Protocol by Pudendal Block in Reconstructive Surgery Clitoral " Pudendal Block in Clitoral Surgery (Pain REparation CLItoris)
- ClinicalTrials.gov ID
- NCT05058248
- Acronym / sponsor ID
- DORECLI / CHIM -RIPH2-001
- Keywords
- excision, Reconstructive surgery of the clitoris, sexual health, chronic pain,, The pudendal block nerve endings., postoperative pain in clitoral surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Raincy Montfermeil Hospital GroupResearch network
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 27 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Pudendal block | Active comparator | Procedure: pudendal blockUltrasound-guided bilateral pudendal block at the start of surgery, in gynecological position: injection of 15 mL of 0.475% Naropein in each ischiorectal fossa. |
| the standard method | Other | Procedure: pudendal blockOperated and anesthetized patients according to the standard method within the department |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Major patient,
- With the indication of a clitoral repair surgery
- Having expressed their free and informed written consent
- Affiliated with a social security scheme
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pudendal blockAlso: standard methodgeneral anesthesia with an intravenous analgesic protocol then oral without anesthesia regional loco | Procedure or surgery | Pudendal block, the standard method |
Primary outcome
decrease in the mean of the self-reported pain scores in the first 24 hours
Time frame: 24 hours
decrease in the mean of the self-reported pain scores in the first 24 hours using a Numerical visual scale
1 secondary outcome
decrease in pain on the EVN at 2 hours, 6 hours , Day 1 and Day 7 postoperative
Time frame: 2 hours, 6 hours, Day 1 and Day 7 postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pudendal block in people with Reduction in Pain Within 24 Hours of Surgery, run by Raincy Montfermeil Hospital Group at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mathieux CAMBY, MD (+33149203040, mathieu.camby@ght-gpne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
decrease in the mean of the self-reported pain scores in the first 24 hours (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2022.