NCT01191593CompletedPhase 4
The Efficacy of Adductor-Canal-Blockade on Pain and Morphine Consumption After Revision Knee Arthroplasty
Rigshospitalet, Denmark1 site in 1 country36 target enrollmentStarted: September 1, 2010Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Pain during 45 degrees active flexion of the knee
Study Overview
Brief Summary
The purpose of this study is to determine whether Adductor-Canal-Blockade is effective at reducing pain and morphine consumption after revision knee arthroplasty.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Revision Knee Arthroplasty in general anaesthesia
- •American society of anesthesiologists (ASA) 1-3
- •BMI 18-40
- •Written informed consent
Exclusion Criteria
- •Can not cooperate to the exam
- •Do not speak or understand Danish
- •Drug allergy
- •Alcohol or drug abuse
Arms & Interventions
Adductor-Canal-Blockade with ropivacaine
Experimental
Intervention: Adductor-Canal-Blockade with Ropivacaine (Procedure)
Adductor-Canal-blockade with saline
Placebo Comparator
Intervention: Adductor-Canal-blockade with saline (Procedure)
Outcomes
Primary Outcomes
Pain during 45 degrees active flexion of the knee
Time Frame: 4 hours postoperative
0-100 mm at a visual analogue scale (VAS), at 4 hours postoperative.
Secondary Outcomes
- Pain during 45 degrees active flexion of the knee(24 hours postoperative)
- Pain during rest(24 hours postoperative)
- Total morphine consumption(0-24 hours postoperative)
- Postoperative nausea(24 hours postoperative)
- Postoperative vomiting(0-24 hours postoperative)
- Zofran consumption(0-24 hours postoperative)
- Sedation(24 hours postoperative)
- Pain during 45 degrees active flexion of the knee(1-8 hours postoperative)
- Pain during rest(1-8 hours postoperative)
- Postoperative nausea(1-8 hours postoperative)
- Sedation(1-8 hours postoperative)
Investigators
Pia Jaeger
M.D.
Rigshospitalet, Denmark
Study Sites (1)
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