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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain After Total Knee Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm RP

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

Group Type OTHER

Ropivacaine

Intervention Type DRUG

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.

Saline

Intervention Type DRUG

please see intervention description for ropivacaine

Arm PR

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

Group Type OTHER

Ropivacaine

Intervention Type DRUG

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.

Saline

Intervention Type DRUG

please see intervention description for ropivacaine

Interventions

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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.

Intervention Type DRUG

Saline

please see intervention description for ropivacaine

Intervention Type DRUG

Other Intervention Names

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Naropin NaCl, placebo

Eligibility Criteria

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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