EUCTR2021-000429-28-DK
Active, not recruiting
Phase 1
Combined intravenous dexamethasone and dexmedetomidine as adjuncts to popliteal and saphenous nerve blocks in patients undergoing orthopaedic surgery of the foot and ankle. A randomised, blinded, placebo-controlled, parallel clinical trial.
Zealand University Hospital, Department of Anaesthesiology0 sites120 target enrollmentFebruary 19, 2021
ConditionsParticipants undergoing osseous surgery of the foot or ankle with a popliteal and saphenous nerve blocks as means of providing anagelsia with general anaesthesia will be investigated.MedDRA version: 20.0Level: LLTClassification code 10038286Term: Regional nerve blockSystem Organ Class: 100000004865Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Participants undergoing osseous surgery of the foot or ankle with a popliteal and saphenous nerve blocks as means of providing anagelsia with general anaesthesia will be investigated.
- Sponsor
- Zealand University Hospital, Department of Anaesthesiology
- Enrollment
- 120
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Scheduled for unilateral osseous surgery of the ankle or foot
- •General anaesthesia with both a popliteal and a saphenous nerve block for postoperative analgesia.
- •Age of 18 or above.
- •American Society of Anaesthesiologists Physical Status Score of 1 to 3\.
- •Body Mass Index of 18 to 40, but a minimum weight of 50 kg.
- •For fertile women, negative urine humane choriongonadotropine test or use of safe anti\-conception.
- •Ability to understand the trial protocol, risks, benefits, and provide signed informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- •Inability to read and understand Danish.
- •Uncooperativeness.
- •Participation in another trial involving medication.
- •Allergy to study medication.
- •Daily use of opioids above 30 mg/day morphine (or equivalents).
- •Daily use of corticosteroids of more than 5 mg prednisolone equivalents within the past one month.
- •Neurological or musculoskeletal disease making block performance impossible.
- •Dysregulated diabetes (as judged by investigators).
- •Dysregulated anticoagulants (as judged by investigators).
- •History of drug or alcohol abuse.
Outcomes
Primary Outcomes
Not specified
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