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Clinical Trials/NCT01549704
NCT01549704
Completed
Phase 4

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

University Hospital, Gentofte, Copenhagen1 site in 1 country50 target enrollmentFebruary 2012

Overview

Phase
Phase 4
Intervention
Ropivacaine
Conditions
Pain After Total Knee Arthroplasty
Sponsor
University Hospital, Gentofte, Copenhagen
Enrollment
50
Locations
1
Primary Endpoint
Difference in VAS between ACB and placebo during active 45 degrees knee flexion
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2012
End Date
December 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Gentofte, Copenhagen
Responsible Party
Principal Investigator
Principal Investigator

Ulrik Grevstad

Consultant

University Hospital, Gentofte, Copenhagen

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

Arm RP

first blockade: ropivacaine 7,5mg/ml 30 ml second blockade: placebo: saline 30 ml

Intervention: Ropivacaine

Arm RP

first blockade: ropivacaine 7,5mg/ml 30 ml second blockade: placebo: saline 30 ml

Intervention: Saline

Arm PR

first blockade: placebo: saline 30 ml second blockade: ropivacaine 7,5mg/ml 30 ml

Intervention: Ropivacaine

Arm PR

first blockade: placebo: saline 30 ml second blockade: ropivacaine 7,5mg/ml 30 ml

Intervention: Saline

Outcomes

Primary Outcomes

Difference in VAS between ACB and placebo during active 45 degrees knee flexion

Time Frame: 45 minutes

Secondary Outcomes

  • Difference in mean VAS between the groups at rest(15, 30, 60, 75 and 90 minutes)
  • Difference in mean VAS between the groups during active knee flexion(15, 30, 60, 75 and 90 minutes)

Study Sites (1)

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