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Spinal versus General Anaesthesia in Surgery for Inguinodynia: a Randomized Controlled Trial (SPINAZIE trial)

Spinal versus General Anaesthesia in Surgery for Inguinodynia: a Randomized Controlled Trial (SPINAZIE trial) - RCT Spinal versus General Anaesthesia for Groin Pain Surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON42411
Enrollment
190
Registered
2015-12-04
Start date
2016-01-13
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pijn groin pain inguinodynia

Interventions

Patients are randomized between spinal and general anaesthesia. The conventional protocols are used for the types of anaesthesia.

Sponsors

Maxima Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - 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.

Exclusion criteria

Exclusion criteria: - 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.

Design outcomes

Secondary

MeasureTime frame
Secondary outcome measures are differences between the setting of anaesthesia regarding the origin of groin pain, types of remedial surgery, preoperative use of analgesics, direct and indirect costs of the intervention and complication rates.

Primary

MeasureTime frame
Primary outcome is the reduction of postoperative pain, patient satisfaction and quality of life, on short (

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)