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Spinal versus General Anaesthesia in Surgery for Inguinodynia: a Randomized Controlled Trial


- candidate number23615
- NTR NumberNTR5586
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-jan-2016
- Secondary IDsNL54115.015.15 
- Public TitleSpinal versus General Anaesthesia in Surgery for Inguinodynia: a Randomized Controlled Trial
- Scientific TitleSpinal versus General Anaesthesia in Surgery for Inguinodynia: a Randomized Controlled Trial
- ACRONYMSPINAZIE trial
- hypothesisSpinal anaesthesia is superior compared to general anaesthesia in terms of pain relief following remedial surgery for chronic groin pain.
- Healt Condition(s) or Problem(s) studiedInguinodynia
- Inclusion criteriaPatients 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.
- Exclusion criteriaGroin 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 13-jan-2016
- planned closingdate31-dec-2019
- Target number of participants190
- Interventionsspinal anaesthesia or general anaesthesia (during remedial surgery)
- Primary outcomeEffect of type of anaesthesia on pain relief (using Numerical Rating Scale) after remedial surgery
- Secondary outcomeEffect of type of anaesthesia on:
1. quality of life (using Short Form Health Survery-12)
2. patient satisfaction
3. differences in pain medication
4. direct and indirect medical costs
5. complication rate
- TimepointsPostoperative after 1 week, 6 weeks, 3 months (short term)
Postoperative after 6 months and 1 year
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES SolviMáx
- CONTACT for SCIENTIFIC QUERIESMD/MSc W.A.R. Zwaans
- Sponsor/Initiator Máxima Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Maxima Medical Center
- Publications
- Brief summaryBackground
Inguinodynia is a common complication following inguinal hernia repair, but may also be found after other types of (groin) surgery. If conservative treatments are to no avail, tailored remedial surgery may be considered. Remedial surgery includes a neurectomy and/or a (partial) meshectomy. Two retrospective studies in patients with chronic inguinodynia suggested that spinal anaesthesia is superior compared to general anaesthesia in terms of pain relief following these operations. This randomized controlled trial is designed to confirm the effect of the type of anaesthesia (spinal or general) on pain relief following remedial surgery for inguinodynia.

Methods
A total of 190 adult patients who suffer from unacceptable chronic (>3 months) inguinodynia, as subjectively judged by patients themselves, are included. Only patients scheduled to undergo remedial surgery including a neurectomy and/or a meshectomy by an open approach are considered for inclusion and randomized to spinal or general anaesthesia. Patients are excluded if pain is attributable to abdominal causes or if any contra-indications for either type of anaesthesia are present. Patients will be followed-up up to one year postoperatively. Primary outcome is the effect on the type of anaesthesia on pain relief. Secondary outcomes include patient satisfaction, quality of life, use of analgesics and (in)direct medical costs.
- Main changes (audit trail)
- RECORD15-jan-2016 - 14-feb-2016


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