Spinal versus General Anaesthesia in Surgery for Inguinodynia: a Randomized Controlled Trial (SPINAZIE trial)
- Conditions
- pijngroin paininguinodynia
- Registration Number
- NL-OMON42411
- Lead Sponsor
- Maxima Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 190
- Patients aged >18 years suspected for a groin pain syndrome (based on patient history, physical examination and diagnostic injection (10cc lidocaine 1-2% with or without corticosteroids);
- Persisting groin pain >=3 months;
- Unacceptable pain levels (subjective by patient) despite one or several injections with local anaesthetics or other conservative treatments;
- Groin pain with origin in one of the three inguinal nerves or inserted mesh;
- Neurectomy and/or meshectomy by an open approach;
- Informed consent obtained.
- Groin pain caused by intercostal neuralgia (lower abdominal cutaneous nerve entrapment syndrome (ACNES));
- Involvement of the lateral femoral cutaneous nerve;
- Pregnancy;
- Contra-indications for general or spinal anesthesia;
- Indication for retroperitoneal neurectomy;
- Cognitive impairment;
- Malignancy;
- Previous remedial surgery on same site in MMC;
- Bilateral groin pain sugery;
- ASA class >III;
- Pre-existant neurological deficiency;
- Inability to speak or understand the Dutch language.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome is the reduction of postoperative pain, patient satisfaction<br /><br>and quality of life, on short (<3 months) and long term (up to 1 year).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome measures are differences between the setting of anaesthesia<br /><br>regarding the origin of groin pain, types of remedial surgery, preoperative use<br /><br>of analgesics, direct and indirect costs of the intervention and complication<br /><br>rates.</p><br>