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Clinical Trials/EUCTR2015-001108-76-DK
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

Sponsor
Herlev Hospital, Department of Anaesthesiology I65N9

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