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

University Hospital, Gentofte, Copenhagen

Status and phase: Completed; Phase 4

Conditions: Pain After Total Knee Arthroplasty

Treatments: Drug: Saline; Drug: Ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01549704

SM1-UG-11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

Arm RP

Other group

Description:

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

Treatment:

Drug: Ropivacaine

Drug: Saline

Arm PR

Other group

Description:

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

Treatment:

Drug: Ropivacaine

Drug: Saline