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

Phase 4

Completed

• Conditions: Pain After Total Knee Arthroplasty
• Interventions: Drug: Ropivacaine; Drug: Saline

• Registration Number: NCT01549704
• Lead Sponsor: University Hospital, Gentofte, Copenhagen

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 Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-03-01
• Study First Submitted QC: 2012-03-08
• Study First Posted: 2012-03-09
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-07
• Last Update Posted: 2013-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm RP	Saline	first blockade: ropivacaine 7,5mg/ml 30 ml second blockade: placebo: saline 30 ml
Arm PR	Saline	first blockade: placebo: saline 30 ml second blockade: ropivacaine 7,5mg/ml 30 ml
Arm RP	Ropivacaine	first blockade: ropivacaine 7,5mg/ml 30 ml second blockade: placebo: saline 30 ml
Arm PR	Ropivacaine	first blockade: placebo: saline 30 ml second blockade: ropivacaine 7,5mg/ml 30 ml

Primary Outcome Measures

Name	Time	Method
Difference in VAS between ACB and placebo during active 45 degrees knee flexion	45 minutes

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Gentofte Hospital; 🇩🇰 Copenhagen, Denmark