The Efficacy of Adductor-Canal-Blockade on Pain and Morphine Consumption After Total Knee Arthroplasty
2 other identifiers
interventional
40
1 country
1
Brief Summary
The objective of this study is to assess the efficacy of Adductor-Canal-Blockade on pain and morphine consumption after total knee arthroplasty. Our hypothesis is that the Adductor -Canal-Blockade is superior to placebo in reducing pain and morphine consumption after total knee arthroplasty.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 postoperative-pain
Started Jan 2011
Shorter than P25 for phase_4 postoperative-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2010
CompletedFirst Posted
Study publicly available on registry
December 17, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedOctober 4, 2011
October 1, 2011
8 months
December 16, 2010
October 3, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain during 45 degrees active flexion of the knee
0-100 mm at a visual analogue scale (VAS), at 1 hour postoperative
1 hour postoperative
Secondary Outcomes (8)
Pain during 45 degrees active flexion of the knee
0-6 hours postoperative
Pain during rest
1-6 hours postoperative
A change in pain score in the ropivacaine group, after activating the block
30-60 minutes postoperative
Total morphine consumption
30 minutes - 6 hours postoperative
Postoperative nausea
1-6 hours postoperative
- +3 more secondary outcomes
Study Arms (2)
Adductor-Canal-Blockade with Ropivacaine
ACTIVE COMPARATORAdductor-Canal-blockade with saline
PLACEBO COMPARATORInterventions
US-guided Adductor-Canal-Blockade with ropivacaine 7,5 mg/ml
US-guided Adductor-Canal-blockade with saline
Eligibility Criteria
You may qualify if:
- Total Knee Arthroplasty in general anaesthesia
- ASA 1-3
- BMI 18-40
- Written informed consent
You may not qualify if:
- Can not cooperate to the exam
- Do not speak or understand Danish
- Drug allergy
- Alcohol or drug abuse
- Daily consumption of strong opioids
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anaesthesia-Surgery-Intensive Care, Gentofte Hospital
Gentofte Municipality, Hellerup, 2900, Denmark
Related Publications (1)
Jaeger P, Grevstad U, Henningsen MH, Gottschau B, Mathiesen O, Dahl JB. Effect of adductor-canal-blockade on established, severe post-operative pain after total knee arthroplasty: a randomised study. Acta Anaesthesiol Scand. 2012 Sep;56(8):1013-9. doi: 10.1111/j.1399-6576.2012.02737.x. Epub 2012 Jul 26.
PMID: 22834681DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pia Jæger, MD
Rigshospitalet, Denmark
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
December 16, 2010
First Posted
December 17, 2010
Study Start
January 1, 2011
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
October 4, 2011
Record last verified: 2011-10