About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
This cohort study is a pilot study to 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
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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
Numeric pain scale (0 "no pain" to 10 "maximal pain")
Secondary outcomes
Report all complications during the follow-up
Complications are evaluated with Clavien-Dindo classification (Grade I to V(death))
Evaluate the effect of the surgical technique on anxiety
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
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
Post-traumatic stress syndrome is evaluated with PCL-5 (post-traumatic stress disorder checklist with a PTSD since score 38