EUCTR2017-002280-18-DK
Active, not recruiting
Phase 1
Catheter-based peripheral regional anaesthesia after orthopaedic surgery: Comparison of low dose, automated periodic infusions with conventional high dose, continuous infusion, and patient-initiated infusions only. A non-inferiority, randomised, controlled trial. - Focus on Infusion in Peripheral Regional Anaesthesia
ordsjællands Hospital Hillerød0 sites270 target enrollmentJuly 10, 2017
ConditionsPostoperative pain, after orthopaedic surgery.MedDRA version: 20.0 Level: PT Classification code 10029173 Term: Nerve block System Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Postoperative pain, after orthopaedic surgery.
- Sponsor
- ordsjællands Hospital Hillerød
- Enrollment
- 270
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Substudy one:
- •1\.\=18 years of age
- •2\.Scheduled for elective shoulder arthroplasty, rotator cuff repair, or Bankart operation
- •3\.ASA classification24 \= III
- •4\.Agreement to the trial protocol
- •Substudy two:
- •1\) Age \= 18 years
- •2\) American Society of Anesthesiologists Classification I\-III
- •3\) Normal cognitive function in order to sign written, informed consent
- •and to understand trial protocol
Exclusion Criteria
- •Substudy one:
- •1\.Body weight \= 50 kg
- •2\.Allergy to local anaesthetics
- •3\.Mental or cognitive disease that impede compliance
- •4\.Contraindication of interscalene brachial plexus nerve block (i.e. pneumothorax, severe pulmonary disease)
- •5\.Anatomic abnormalities preventing successful US\-guided Certa Catheter™ insertion.
- •6\.Pregnancy or breastfeeding
- •Substudy two and three:
- •1\) Allergy to LA
- •2\) Infection in or near insertion site of the peripheral nerve catheter
Outcomes
Primary Outcomes
Not specified
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