EUCTR2015-001108-76-DKActive, not recruitingPhase 1
AnAnkle Trial: Peripheral nerve block vs. spinal anaesthesia for ankle fracture surgery – implications on pain profile and quality of recovery - AnAnkle Trial
Herlev Hospital, Department of Anaesthesiology I65N90 sitesStarted: March 19, 2015Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •-Patients > 18 years old scheduled for internal fixation of an ankle fracture (malleolar fracture).
- •-Ability to read and understand Danish and give informed oral and written consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
Exclusion Criteria
- •-Allergy towards any drug in trial protocol
- •-Bodyweight < 52 kg
- •-Contraindications for SA according to national guidelines
- •-Current gastro-intestinal bleeding
- •-Proximal fibular fracture or multitrauma/other fractures
- •-Cognitive or psychiatric dysfunction or alcohol/narcotic substance abuse causing expected inability to comply with study protocol as evaluated by anaesthesiologist/investigator
- •-No available anaesthesiologist with PNB capability at scheduled time of operation
- •-Neuropathy / neurological dysfunction in the lower extremities
- •-Habitual daily use of opioids
- •-Pregnancy (known or suspected) or breastfeeding
- •-Infection at anaesthesia injection site
- •-Nephropathy requiring dialysis
- •-Acute porphyria
Investigators
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