The Efficacy of Adductor-Canal-Blockade on Pain and Morphine Consumption After Revision Knee Arthroplasty
Primary Purpose
Postoperative Pain, Knee Arthroplasty
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Adductor-Canal-Blockade with Ropivacaine
Adductor-Canal-blockade with saline
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring Adductor-Canal-Blockade, postoperative pain, US-guided nerve block, revision knee arthroplasty
Eligibility Criteria
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
Sites / Locations
- Department of Anaesthesia and Surgery, HOC, Rigshospitalet, Denmark
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Adductor-Canal-Blockade with ropivacaine
Adductor-Canal-blockade with saline
Arm Description
Outcomes
Primary Outcome Measures
Pain during 45 degrees active flexion of the knee
0-100 mm at a visual analogue scale (VAS), at 4 hours postoperative.
Secondary Outcome Measures
Pain during 45 degrees active flexion of the knee
0-100 mm at a visual analogue scale (VAS), registered at the intervals 1, 2, 4, 6 and 8 hours postoperative, calculated as "the area under the curve" (AUC) for the interval 1-8 hours postoperative.
Pain during 45 degrees active flexion of the knee
0-100 mm at a visual analogue scale (VAS), at 24 hours postoperative.
Pain during rest
0-100 mm at a visual analogue scale (VAS), registered at the intervals 1, 2, 4, 6 and 8 hours postoperative, calculated as "the area under the curve" (AUC) for the interval 1-8 hours postoperative.
Pain during rest
0-100 mm at a visual analogue scale (VAS), at 24 hours postoperative.
Total morphine consumption
Total morphine consumption at the intervals 0-8, 8-24 and 0-24 hours postoperative.
Postoperative nausea
Nausea scores(0-3)registered at 1,2,4,6 and 8 hours postoperative, calculated as mean value for the interval 1-8 hours postoperative.
Postoperative nausea
Nausea score(0-3)at 24 hours postoperative.
Postoperative vomiting
Number of vomiting episodes at the intervals 0-8, 8-24 and 0-24 hours postoperative.
Zofran consumption
Total zofran consumption at the intervals 0-8, 8-24 and 0-24 hours postoperative.
Sedation
Sedation score (0-3) registered at 1,2,4,6 and 8 hours postoperative, calculated as the mean value for the interval 1-8 hours postoperative.
Sedation
Sedation score (0-3) at 24 hours postoperative.
Full Information
NCT ID
NCT01191593
First Posted
August 30, 2010
Last Updated
August 21, 2013
Sponsor
Rigshospitalet, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT01191593
Brief Title
The Efficacy of Adductor-Canal-Blockade on Pain and Morphine Consumption After Revision Knee Arthroplasty
Official Title
The Efficacy of Adductor-Canal-Blockade on Pain and Morphine Consumption After Revision Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Knee Arthroplasty
Keywords
Adductor-Canal-Blockade, postoperative pain, US-guided nerve block, revision knee arthroplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adductor-Canal-Blockade with ropivacaine
Arm Type
Experimental
Arm Title
Adductor-Canal-blockade with saline
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
Adductor-Canal-Blockade with Ropivacaine
Other Intervention Name(s)
Naropine, Postoperative pain, US-guided nerve block
Intervention Description
US-guided Adductor-Canal-Blockade with ropivacaine 7,5 mg/ml
Intervention Type
Procedure
Intervention Name(s)
Adductor-Canal-blockade with saline
Other Intervention Name(s)
Placebo block
Intervention Description
US-guided Adductor-Canal-blockade with saline
Primary Outcome Measure Information:
Title
Pain during 45 degrees active flexion of the knee
Description
0-100 mm at a visual analogue scale (VAS), at 4 hours postoperative.
Time Frame
4 hours postoperative
Secondary Outcome Measure Information:
Title
Pain during 45 degrees active flexion of the knee
Description
0-100 mm at a visual analogue scale (VAS), registered at the intervals 1, 2, 4, 6 and 8 hours postoperative, calculated as "the area under the curve" (AUC) for the interval 1-8 hours postoperative.
Time Frame
1-8 hours postoperative
Title
Pain during 45 degrees active flexion of the knee
Description
0-100 mm at a visual analogue scale (VAS), at 24 hours postoperative.
Time Frame
24 hours postoperative
Title
Pain during rest
Description
0-100 mm at a visual analogue scale (VAS), registered at the intervals 1, 2, 4, 6 and 8 hours postoperative, calculated as "the area under the curve" (AUC) for the interval 1-8 hours postoperative.
Time Frame
1-8 hours postoperative
Title
Pain during rest
Description
0-100 mm at a visual analogue scale (VAS), at 24 hours postoperative.
Time Frame
24 hours postoperative
Title
Total morphine consumption
Description
Total morphine consumption at the intervals 0-8, 8-24 and 0-24 hours postoperative.
Time Frame
0-24 hours postoperative
Title
Postoperative nausea
Description
Nausea scores(0-3)registered at 1,2,4,6 and 8 hours postoperative, calculated as mean value for the interval 1-8 hours postoperative.
Time Frame
1-8 hours postoperative
Title
Postoperative nausea
Description
Nausea score(0-3)at 24 hours postoperative.
Time Frame
24 hours postoperative
Title
Postoperative vomiting
Description
Number of vomiting episodes at the intervals 0-8, 8-24 and 0-24 hours postoperative.
Time Frame
0-24 hours postoperative
Title
Zofran consumption
Description
Total zofran consumption at the intervals 0-8, 8-24 and 0-24 hours postoperative.
Time Frame
0-24 hours postoperative
Title
Sedation
Description
Sedation score (0-3) registered at 1,2,4,6 and 8 hours postoperative, calculated as the mean value for the interval 1-8 hours postoperative.
Time Frame
1-8 hours postoperative
Title
Sedation
Description
Sedation score (0-3) at 24 hours postoperative.
Time Frame
24 hours postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pia Jæger, MD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anaesthesia and Surgery, HOC, Rigshospitalet, Denmark
City
Copenhagen
State/Province
København Ø
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
25386752
Citation
Jaeger P, Koscielniak-Nielsen ZJ, Schroder HM, Mathiesen O, Henningsen MH, Lund J, Jenstrup MT, Dahl JB. Adductor canal block for postoperative pain treatment after revision knee arthroplasty: a blinded, randomized, placebo-controlled study. PLoS One. 2014 Nov 11;9(11):e111951. doi: 10.1371/journal.pone.0111951. eCollection 2014.
Results Reference
derived
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The Efficacy of Adductor-Canal-Blockade on Pain and Morphine Consumption After Revision Knee Arthroplasty
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