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Clinical Trials/EUCTR2015-001108-76-DK
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.

Registry
who.int
Start Date
March 19, 2015
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Herlev Hospital, Department of Anaesthesiology I65N9

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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