Effect of Adductor-Canal-Blockade on High Pain Responders After Total Knee Arthroplasty

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Ulrik Grevstad, University Hospital, Gentofte, Copenhagen

ClinicalTrials.gov Identifier:

NCT01549704

First received: March 1, 2012

Last updated: January 7, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

March 1, 2012

Last Updated Date

January 7, 2013

Start Date ^ICMJE

February 2012

Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Difference in VAS between ACB and placebo during active 45 degrees knee flexion [ Time Frame: 45 minutes ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Difference in VAS between ACB and placebo during active 45 degrees knee flexion [ Time Frame: 45 minutes after the first blockade ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01549704 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Difference in mean VAS between the groups during active knee flexion [ Time Frame: 15, 30, 60, 75 and 90 minutes ] [ Designated as safety issue: No ]
Difference in mean VAS between the groups at rest [ Time Frame: 15, 30, 60, 75 and 90 minutes ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Difference in VAS between ACB and placebo at rest [ Time Frame: 15, 30, 45, 60, 75, 90 after the first blockade ] [ Designated as safety issue: No ]
Difference in VAS between ACB and placebo during active 45 degrees knee flexion [ Time Frame: 15, 30, 60, 75, 90 minutes after the first blockade ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effect of Adductor-Canal-Blockade on High Pain Responders After Total Knee Arthroplasty

Official Title ^ICMJE

Effect of Adductor-Canal-Blockade on High Pain Responders the 1. or 2. Postoperative Day After Total Knee Arthroplasty

Brief Summary

The purpose of this study is to determine whether Adductor-Canal-Blockade (ACB) is superior to placebo when it comes to analgetic efficacy in high pain responders after Total Knee Arthroplasty (TKA). High pain responders are defined as patients reporting VAS > 60 during knee flexion the 1. or 2. day after surgery.

Detailed Description

The patients will be included the 1. or 2. day after surgery. All TKA patients will be screened. Those reporting VAS > 60 during active 45 degrees knee flexion will be asked to participate.

Included patients will receive 2xACB (singleshot) first placebo (30ml saline) and then ropivacaine (30ml ropivacaine 7,5mg/ml) or the other way around (randomized). There will be 45 minutes between the two blockades. The blockades will be ultrasound guided.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Pain After Total Knee Arthroplasty

Intervention ^ICMJE

Drug: Ropivacaine
Arm RP is receiving 30 ml of ropivacaine 7,5 mg/ml at first blockade (ACB) and after 45 minutes another blockade (ACB) with placebo (saline 30 ml).

Arm PR is receiving 30 ml of placebo (saline) at first blockade (ACB) and after 45 minutes another blockade (ACB)with ropivacaine.

Other Name: Naropin
Drug: Saline
please see intervention description for ropivacaine

Other Name: NaCl, placebo

Study Arm (s)

Arm RP
first blockade: ropivacaine 7,5mg/ml 30 ml second blockade: placebo: saline 30 ml
Interventions:
- Drug: Ropivacaine
- Drug: Saline
Arm PR
first blockade: placebo: saline 30 ml second blockade: ropivacaine 7,5mg/ml 30 ml
Interventions:
- Drug: Ropivacaine
- Drug: 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

Completed

Enrollment ^ICMJE

Completion Date

December 2012

Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

TKA within 48 hours and VAS>60 during active 45 degrees knee flexion despite conventional pain medication.
Informed consent
ASA 1-3
BMI 18-40

Exclusion Criteria:

Unable to communicate in Danish
Allergic reactions toward drugs used in the
Abuse of alcohol/drugs
Unable to cooperate

Gender

Both

Ages

30 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT01549704

Other Study ID Numbers ^ICMJE

SM1-UG-11

Has Data Monitoring Committee

Yes

Responsible Party

Ulrik Grevstad, University Hospital, Gentofte, Copenhagen

Study Sponsor ^ICMJE

University Hospital, Gentofte, Copenhagen

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Ulrik Grevstad, MD

Gentofte Hospital

Information Provided By

University Hospital, Gentofte, Copenhagen

Verification Date

January 2013

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

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