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OpenTrials
Completed

NCT Number: NCT01549704

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

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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Key information

Conditions

Pain After Total Knee Arthroplasty

Age range

30 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Gentofte Hospital

Copenhagen, 2900, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine

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.

Other names: Naropin

Saline

Drug

please see intervention description for ropivacaine

Other names: NaCl, placebo

Primary outcomes

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

    Time frame: 45 minutes

Secondary outcomes

  1. Difference in mean VAS between the groups during active knee flexion

    Time frame: 15, 30, 60, 75 and 90 minutes

  2. Difference in mean VAS between the groups at rest

    Time frame: 15, 30, 60, 75 and 90 minutes

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 9, 2012
Registry last updated
Jan 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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