AnAnkle Trial: Peripheral nerve block vs. spinal anaesthesia for ankle fracture surgery – implications on pain profile and quality of recovery

Phase 1

Conditions: Ankle fracture (anaesthesia for surgery)
MedDRA version: 18.0Level: LLTClassification code 10054865Term: Malleolar fractureSystem Organ Class: 100000004863
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2015-001108-76-DK

Lead Sponsor: Herlev Hospital, Department of Anaesthesiology I65N9

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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