The Efficacy of Adductor-Canal-Blockade on Morphine Consumption, Pain and Mobilisation After Total Knee Arthroplasty
2 other identifiers
interventional
70
1 country
2
Brief Summary
The purpose of this study is to determine whether Adductor-Canal-Blockade is effective at reducing morphine consumption and pain, and at the same time improving mobilisation after total knee arthroplasty.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Aug 2010
Shorter than P25 for phase_4
2 active sites
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
April 12, 2010
CompletedFirst Posted
Study publicly available on registry
April 16, 2010
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedApril 13, 2011
April 1, 2010
7 months
April 12, 2010
April 12, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total morphine consumption
Total morphine consumption at the interval 0-24 hours postoperative.
0-24 hours postoperative
Secondary Outcomes (9)
Total morphine consumption
0-26 hours postoperative
Pain during rest
0-26 hours postoperative
Pain during 45 degrees active flexion of the knee
0-26 hours postoperative
A change in pain in the placebo group
24-26 hours postoperative
Postoperative nausea
0-26 hours postoperative
- +4 more secondary outcomes
Study Arms (2)
Adductor-Canal-Blockade
EXPERIMENTALAdductor-Canal-Blockade with ropivacaine
Adductor-Canal-blockade with saline
PLACEBO COMPARATORAdductor-Canal-blockade with isotonic saline
Interventions
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 spinal 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
- Unable to complete the Timed Up and Go test preoperatively
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Department of Anaesthesia, Privathospitalet Hamlet, Frederiksberg, Denmark
Copenhagen, Frederiksberg, 2000, Denmark
Department of Surgery and Anaesthesia, Glostrup Hospital
Glostrup Municipality, Glostrup, 2600, Denmark
Related Publications (1)
Jenstrup MT, Jaeger P, Lund J, Fomsgaard JS, Bache S, Mathiesen O, Larsen TK, Dahl JB. Effects of adductor-canal-blockade on pain and ambulation after total knee arthroplasty: a randomized study. Acta Anaesthesiol Scand. 2012 Mar;56(3):357-64. doi: 10.1111/j.1399-6576.2011.02621.x. Epub 2012 Jan 4.
PMID: 22221014DERIVED
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
Study Record Dates
First Submitted
April 12, 2010
First Posted
April 16, 2010
Study Start
August 1, 2010
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
April 13, 2011
Record last verified: 2010-04