Pudendal Nerve Block Clinical Trial
Official title:
Ultrasound-guided Pudendal Nerve Block in Children: A Descriptive Study of Feasibility
Objective: Description of a new transperineal technique of pudendal nerve block (PNB), under
ultrasound-guidance.
Methods : Successive inclusions after parental consent of 60 children undergoing perineal
surgery under general anesthesia and pudendal nerve block. Data were collected from
induction of anesthesia to second post-operative day (24 hrs. after admission in recovery
room). Ease of PNB achievement was the primary objective evaluated. Efficiency in
preoperative and postoperative period was also reported.
Status | Completed |
Enrollment | 196 |
Est. completion date | February 2015 |
Est. primary completion date | February 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 15 Years |
Eligibility |
Inclusion Criteria: 1. Patient hospitalized in pediatric surgery unit for elective perineal surgery to which the use of pudendal block is relevant and current practice. 2. patient physical status score I-III classification 3. Patient of both sexes 4. Patient aged 1 year to 15 years of age 5. Patient whose parents have given their informed consent. 6. Patient affiliated to a social security scheme or of such a regime Exclusion Criteria: 1. Patient who participated in the previous month to a therapeutic trial or currently included in another test 2. Patient with bleeding disorders 3. Patient with infection (Fasciocutaneous subcutaneous) at the puncture area 4. Patient with allergies to local anesthetics 5. patients with a contraindication to general anesthesia |
Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
France | University hospital Lapeyronie | Montpellier |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quality of visualization (with specific scale: good, medium, bad quality) of local anesthetic injection within the ischiorectale pit under ultrasound. | intraoperative | No | |
Secondary | Quality of visualization (with specific scale: good, medium, bad quality) of target anatomical structures, of needle tip | intraoperative | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03973983 -
Comparison of Ultrasound-guided Transgluteal and Finger-guided Transvaginal Pudendal Nerve Block Techniques
|
N/A |