EUCTR2015-001108-76-DK
Active, not recruiting
Phase 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 sitesMarch 19, 2015
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Herlev Hospital, Department of Anaesthesiology I65N9
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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