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

This study is currently recruiting participants.

Verified December 2012 by Rigshospitalet, Denmark

Sponsor:

Information provided by (Responsible Party):

Pia Jaeger, Rigshospitalet, Denmark

ClinicalTrials.gov Identifier:

NCT01191593

First received: August 30, 2010

Last updated: December 17, 2012

Last verified: December 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

August 30, 2010

Last Updated Date

December 17, 2012

Start Date ^ICMJE

September 2010

Estimated Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Pain during 45 degrees active flexion of the knee [ Time Frame: 4 hours postoperative ] [ Designated as safety issue: No ]

0-100 mm at a visual analogue scale (VAS), at 4 hours postoperative.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01191593 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Pain during 45 degrees active flexion of the knee [ Time Frame: 1-8 hours postoperative ] [ Designated as safety issue: No ]
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 [ Time Frame: 24 hours postoperative ] [ Designated as safety issue: No ]
0-100 mm at a visual analogue scale (VAS), at 24 hours postoperative.
Pain during rest [ Time Frame: 1-8 hours postoperative ] [ Designated as safety issue: No ]
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 [ Time Frame: 24 hours postoperative ] [ Designated as safety issue: No ]
0-100 mm at a visual analogue scale (VAS), at 24 hours postoperative.
Total morphine consumption [ Time Frame: 0-24 hours postoperative ] [ Designated as safety issue: No ]
Total morphine consumption at the intervals 0-8, 8-24 and 0-24 hours postoperative.
Postoperative nausea [ Time Frame: 1-8 hours postoperative ] [ Designated as safety issue: No ]
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 [ Time Frame: 24 hours postoperative ] [ Designated as safety issue: No ]
Nausea score(0-3)at 24 hours postoperative.
Postoperative vomiting [ Time Frame: 0-24 hours postoperative ] [ Designated as safety issue: No ]
Number of vomiting episodes at the intervals 0-8, 8-24 and 0-24 hours postoperative.
Zofran consumption [ Time Frame: 0-24 hours postoperative ] [ Designated as safety issue: No ]
Total zofran consumption at the intervals 0-8, 8-24 and 0-24 hours postoperative.
Sedation [ Time Frame: 1-8 hours postoperative ] [ Designated as safety issue: No ]
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 [ Time Frame: 24 hours postoperative ] [ Designated as safety issue: No ]
Sedation score (0-3) at 24 hours postoperative.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Postoperative Pain
Knee Arthroplasty

Intervention ^ICMJE

Procedure: Adductor-Canal-Blockade with Ropivacaine
US-guided Adductor-Canal-Blockade with ropivacaine 7,5 mg/ml
Other Names:
- Naropine
- Postoperative pain
- US-guided nerve block
Procedure: Adductor-Canal-blockade with saline
US-guided Adductor-Canal-blockade with saline

Other Name: Placebo block

Study Arm (s)

Experimental: Adductor-Canal-Blockade with ropivacaine
Intervention: Procedure: Adductor-Canal-Blockade with Ropivacaine
Placebo Comparator: Adductor-Canal-blockade with saline
Intervention: Procedure: Adductor-Canal-blockade with saline

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2013

Estimated Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

40 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Pia Jæger, MD	0045 3545 3487	pia.jaeger@rh.regionh.dk
Contact: Jørgen B. Dahl, MD, DMSc,MBAex	0045 3545 8837	joergen.b.dahl@rh.regionh.dk

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT01191593

Other Study ID Numbers ^ICMJE

SM1-PJ-10, 2010-021161-71

Has Data Monitoring Committee

Yes

Responsible Party

Pia Jaeger, Rigshospitalet, Denmark

Study Sponsor ^ICMJE

Rigshospitalet, Denmark

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Pia Jæger, MD

Rigshospitalet, Denmark

Information Provided By

Rigshospitalet, Denmark

Verification Date

December 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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