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The Efficacy of Adductor-Canal-Blockade on Pain and Morphine Consumption After Total 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
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Adductor-Canal-Blockade, postoperative pain, US-guided nerve block, total knee arthroplasty

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Total Knee Arthroplasty in general anaesthesia
  • 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
  • Daily consumption of strong opioids

Sites / Locations

  • Department of Anaesthesia-Surgery-Intensive Care, Gentofte Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

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 1 hour 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, 3, 4, 5 and 6 hours postoperative, calculated as "the area under the curve" (AUC) for the interval 1-6 hours postoperative.
Pain during rest
0-100 mm at a visual analogue scale (VAS), registered at the intervals 1, 2, 3, 4, 5 and 6 hours postoperative, calculated as "the area under the curve" (AUC) for the interval 1-6 hours postoperative.
A change in pain score in the ropivacaine group, after activating the block
0-100 mm at a visual analogue scale (VAS), at 30 and 60 minutes postoperative. A change in pain score in the ropivacaine group compared to the placebo group, after activating the block.
Total morphine consumption
Total morphine consumption at the interval 30 minutes - 6 hours postoperative.
Postoperative nausea
Nausea scores(0-3)registered at 1, 2, 3, 4, 5 and 6 hours postoperative, calculated as mean value for the interval 1-6 hours postoperative.
Postoperative vomiting
Number of vomiting episodes at the interval 1-6 hours postoperative.
Zofran consumption
Total zofran consumption at the intervals 1-6 hours postoperative.
Sedation
Sedation score (0-3) registered at 1, 2, 3, 4, 5 and 6 hours postoperative, calculated as the mean value for the interval 1-6 hours postoperative.

Full Information

First Posted
December 16, 2010
Last Updated
October 3, 2011
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT01261897
Brief Title
The Efficacy of Adductor-Canal-Blockade on Pain and Morphine Consumption After Total Knee Arthroplasty
Official Title
The Efficacy of Adductor-Canal-Blockade on Pain and Morphine Consumption After Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (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 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.

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, total knee arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adductor-Canal-Blockade with Ropivacaine
Arm Type
Active Comparator
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)
Sham 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 1 hour postoperative
Time Frame
1 hour 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, 3, 4, 5 and 6 hours postoperative, calculated as "the area under the curve" (AUC) for the interval 1-6 hours postoperative.
Time Frame
0-6 hours postoperative
Title
Pain during rest
Description
0-100 mm at a visual analogue scale (VAS), registered at the intervals 1, 2, 3, 4, 5 and 6 hours postoperative, calculated as "the area under the curve" (AUC) for the interval 1-6 hours postoperative.
Time Frame
1-6 hours postoperative
Title
A change in pain score in the ropivacaine group, after activating the block
Description
0-100 mm at a visual analogue scale (VAS), at 30 and 60 minutes postoperative. A change in pain score in the ropivacaine group compared to the placebo group, after activating the block.
Time Frame
30-60 minutes postoperative
Title
Total morphine consumption
Description
Total morphine consumption at the interval 30 minutes - 6 hours postoperative.
Time Frame
30 minutes - 6 hours postoperative
Title
Postoperative nausea
Description
Nausea scores(0-3)registered at 1, 2, 3, 4, 5 and 6 hours postoperative, calculated as mean value for the interval 1-6 hours postoperative.
Time Frame
1-6 hours postoperative
Title
Postoperative vomiting
Description
Number of vomiting episodes at the interval 1-6 hours postoperative.
Time Frame
1-6 hours postoperative
Title
Zofran consumption
Description
Total zofran consumption at the intervals 1-6 hours postoperative.
Time Frame
1-6 hours postoperative
Title
Sedation
Description
Sedation score (0-3) registered at 1, 2, 3, 4, 5 and 6 hours postoperative, calculated as the mean value for the interval 1-6 hours postoperative.
Time Frame
1-6 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: Total Knee Arthroplasty in general anaesthesia 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 Daily consumption of strong opioids
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-Surgery-Intensive Care, Gentofte Hospital
City
Gentofte
State/Province
Hellerup
ZIP/Postal Code
2900
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
22834681
Citation
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.
Results Reference
derived

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The Efficacy of Adductor-Canal-Blockade on Pain and Morphine Consumption After Total Knee Arthroplasty

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