Effect of perineural dexamethasone on the duration of popliteal nerve block for analgesia after ankle surgery
Phase 1
- Conditions
- Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]Ankle arthrosis, situation after ankle injury or malposition of ankle/foot, arthrodesis as a curative therapyMedDRA version: 20.0Level: LLTClassification code 10002540Term: Ankle arthrodesisSystem Organ Class: 100000021321
- Registration Number
- EUCTR2017-002185-51-FI
- Lead Sponsor
- Tampere University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
Patient under elective ankle/food arthrodesis
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 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
Exclusion Criteria
Age under 18 years, compicated diabetes mellitus, lack of finnihs language skil and/or co-operation, chronic pain, steroid medication in regular use
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Effect of perineural dexamethasone on the duration of popliteal nerve block after ankle/foot surgery;Secondary Objective: Prolonged postoperative pain after ankle/foot surgery;Primary end point(s): Time for first opioid request from popliteal nerve block placement;Timepoint(s) of evaluation of this end point: 48 hours after popliteal nerve block placement
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Postoperative analgesic consumption, nausea and vomiting, moobilisation, other recovery, long term quality of life and prolonged pain;Timepoint(s) of evaluation of this end point: Maximum 48 hours, quaries at 2 month, 6 month and 12 month postoperatively