The anterior cutaneus nerve entrapment syndrome (ACNES). Randomized double blind controlled trial for the diagnosis and treatment of entrapment of the anterior cutaneus nerve through the rectus muscle.
Completed
- Conditions
- abdominal wall nerve entrapmentACNES1003460610040795
- Registration Number
- NL-OMON32058
- Lead Sponsor
- Máxima Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 44
Inclusion Criteria
Localized abdominal wall pain in the rectus muscle
positive Carnett sign
Exclusion Criteria
Suspected intra-abdominal pain
Anticoagulants use
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The difference in number of patients with a clinically relevant reducion of<br /><br>pain on VAS, 15 min after injection of Lidocain vs saline.<br /><br>The difference in number of patients with a clinically relevant reducion of<br /><br>pain on VAS after neurectomie vs sham operation.<br /><br><br /><br>A more than 50 % reduction on VAS is considered clinically relevant.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Fase 1, Diagnostic<br /><br>* the difference in the number of people with longterm painfree result after<br /><br>diagnostic injection (VAS<10)<br /><br>* the absolute en relative difference on the VAS.<br /><br>* difference on Verbal Rating Score (VRS)<br /><br><br /><br>Fase 2 en 3, therapie<br /><br>* The number of patients pain free at 3 months after injection of lidocaine and<br /><br>Kenacort<br /><br>* Long term evaluation: frequency of patients developping a recurrent pain at<br /><br>the site of surgery after a pain free period (VAS < 10) of at least 6 weeks<br /><br>after neurectomy.<br /><br>* Difference on the VRS<br /><br>* difference in improvement on the SF-36</p><br>