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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ulrik Grevstad, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT01549704
First received: March 1, 2012
Last updated: January 7, 2013
Last verified: January 2013

March 1, 2012
January 7, 2013
February 2012
December 2012   (final data collection date for primary outcome measure)
Difference in VAS between ACB and placebo during active 45 degrees knee flexion [ Time Frame: 45 minutes ] [ Designated as safety issue: No ]
Difference in VAS between ACB and placebo during active 45 degrees knee flexion [ Time Frame: 45 minutes after the first blockade ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01549704 on ClinicalTrials.gov Archive Site
  • Difference in mean VAS between the groups during active knee flexion [ Time Frame: 15, 30, 60, 75 and 90 minutes ] [ Designated as safety issue: No ]
  • Difference in mean VAS between the groups at rest [ Time Frame: 15, 30, 60, 75 and 90 minutes ] [ Designated as safety issue: No ]
  • Difference in VAS between ACB and placebo at rest [ Time Frame: 15, 30, 45, 60, 75, 90 after the first blockade ] [ Designated as safety issue: No ]
  • Difference in VAS between ACB and placebo during active 45 degrees knee flexion [ Time Frame: 15, 30, 60, 75, 90 minutes after the first blockade ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effect of Adductor-Canal-Blockade on High Pain Responders After Total Knee Arthroplasty
Effect of Adductor-Canal-Blockade on High Pain Responders the 1. or 2. Postoperative Day 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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pain After Total Knee Arthroplasty
  • Drug: 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.

    Other Name: Naropin
  • Drug: Saline
    please see intervention description for ropivacaine
    Other Name: NaCl, placebo
  • Arm RP
    first blockade: ropivacaine 7,5mg/ml 30 ml second blockade: placebo: saline 30 ml
    Interventions:
    • Drug: Ropivacaine
    • Drug: Saline
  • Arm PR
    first blockade: placebo: saline 30 ml second blockade: ropivacaine 7,5mg/ml 30 ml
    Interventions:
    • Drug: Ropivacaine
    • Drug: Saline
Grevstad U, Mathiesen O, Lind T, Dahl JB. Effect of adductor canal block on pain in patients with severe pain after total knee arthroplasty: a randomized study with individual patient analysis. Br J Anaesth. 2014 Jan 8. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
30 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01549704
SM1-UG-11
Yes
Ulrik Grevstad, University Hospital, Gentofte, Copenhagen
University Hospital, Gentofte, Copenhagen
Not Provided
Principal Investigator: Ulrik Grevstad, MD Gentofte Hospital
University Hospital, Gentofte, Copenhagen
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP