Spinal versus General Anaesthesia in Surgery for Inguinodynia: a Randomized Controlled Trial
- Conditions
- Chronic inguinodynia
- Registration Number
- NL-OMON25028
- Lead Sponsor
- Máxima Medical Center Veldhoven/Eindhoven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- 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);
Persistent 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 Effect of type of anaesthesia on pain relief (using Numerical Rating Scale) after remedial surgery
- Secondary Outcome Measures
Name Time Method Effect of type of anaesthesia on:<br /><br>1. quality of life (using Short Form Health Survery-12)<br /><br>2. patient satisfaction<br /><br>3. differences in pain medication <br /><br>4. direct and indirect medical costs<br /><br>5. complication rate