Neuralgia, Pudendal Neuralgia
Conditions
Brief summary
Pudendal and inferior cluneal neuralgias are responsible for chronic pelvicperineal pain. These two neuralgias are associated in approximately 25% of cases. In the event of failure of first-line multimodal medical treatment, a mini-invasive robot-assisted laparoscopic decompression can be proposed. These surgeries carry the risk of neurapraxia, leading to a temporary increase in neuropathic pain and numbness in the nerve sensitive area, a motoric or neurovegetative disturbance (pudendal).
Interventions
None listed
Sponsors
UBOSGA
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients over 18 years old * Patients presenting a pudendal and/or inferior cluneal neuralgias with failure of the medical treatment * Patient having given consent after reading the information note
Exclusion criteria
* Inoperable patients (contraindications to anesthesia or surgery) surgical contraindications) * Person deprived of liberty or under guardianship * Person under court protection * Pregnant or breast-feeding woman * Minors
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the 1-year effectiveness of a perioperative medical program on the characteristics of neuropathic pain related to postoperative neurapraxia, following robot-assisted laparoscopic neurolyses of the pudendal and inferior cluneal nerves | Pré-operatively, and then post-operatively : every day the first month, then once a week until the 4th month then at 1 year year after surgery | Numeric pain scale (0 no pain to 10 maximal pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Report all complications during the follow-up | 2 days, 4 months, 1 year after surgery | Complications are evaluated with Clavien-Dindo classification (Grade I to V(death)) |
| Evaluate the effect of the surgical technique on anxiety | Pré-operatively, 2 days, 4 months, 1 year after surgery | Anxiety is evaluated with STAI (State Trait Anxiety Inventory-form) (anxious personality since STAI score 51 for women, and score 61 for men) |
| Evaluate the effect of the surgical technique on depression | Pré-operatively, 2 days, 4 months, 1 year after surgery | Depression is evaluated with Beck inventory (mild to moderate depression since score 10, moderate depression since score 19, severe depression since score 30) |
| Evaluate the effect of the surgical technique on post-traumatic stress syndrome | Pré-operatively, 2 days, 4 months, 1 year after surgery | Post-traumatic stress syndrome is evaluated with PCL-5 (post-traumatic stress disorder checklist with a PTSD since score 38 |
| Evaluate the impact on quality of life | Pré-operatively, 2 days, 4 months, 1 year after surgery | Quality of life is evaluated with SF-36 (36-item Short Form Health Survey) |
Countries
France
Contacts
Primary ContactOlivier Celhay, M.D
Backup ContactAlexandra Dupire
Outcome results
None listed