EUCTR2014-005383-14-DK
Active, not recruiting
Phase 1
Protracted mixture of local anaesthetics for major foot and ankle surgery. A randomized double-blind, controlled study comparing Bupivacaine-epinephrine 0.5% and Bupivacaine-epinepherine 0.5% plus dexamethasone - PROMIX
Aarhus University Hospital0 sitesFebruary 9, 2015
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Aarhus University Hospital
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Age \= 18 years
- •\- Scheduled amputation of the whole foot, parts of the foot or shin with indication for postoperative pain management the form of poplitealt sciatic nerve blockade
- •\- Oral and written informed consent to participate in the study after having understood the contents of the protocol and limitations fully
- •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 28
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 28
Exclusion Criteria
- •Patients meeting one or more of the following exclusion criteria will not be included in the study:
- •\- Patients who can not cooperate with the investigation
- •\- Patients who do not speak and understand English or Danish
- •\- Allergy to drugs used in the study
Outcomes
Primary Outcomes
Not specified
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