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Completed

NCT Number: NCT01104883

The Efficacy of Adductor-Canal-Blockade on Morphine Consumption, Pain and Mobilisation After Total Knee Arthroplasty

The purpose of this study is to determine whether Adductor-Canal-Blockade is effective at reducing morphine consumption and pain, and at the same time improving mobilisation after total knee arthroplasty.

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Key information

Conditions

Total Knee Arthroplasty Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Anaesthesia, Privathospitalet Hamlet, Frederiksberg, Denmark, Copenhagen, Frederiksberg, Denmark

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Total Knee Arthroplasty in spinal anaesthesia
  • ASA 1-3
  • BMI 18-40
  • Written informed consent

Exclusion criteria

  • Can not cooperate to the exam
  • Do not speak or understand Danish
  • Drug allergy
  • Alcohol or drug abuse
  • Daily consumption of strong opioids
  • Unable to complete the Timed Up and Go test preoperatively

Treatment and study plan

Adductor-Canal-Blockade

Procedure

US-guided Adductor-Canal-Blockade with ropivacaine 7,5 mg/ml

Other names: Naropine, Postoperative pain, US-guided nerve block

Adductor-Canal-blockade with saline

Procedure

US-guided Adductor-Canal-blockade with saline

Other names: placebo block

Primary outcomes

  1. Total morphine consumption

    Time frame: 0-24 hours postoperative

    Total morphine consumption at the interval 0-24 hours postoperative.

Secondary outcomes

  1. Total morphine consumption

    Time frame: 0-26 hours postoperative

    Total morphine consumption at the intervals 0-2, 0-4, 0-8 and 0-26 hours postoperative.

  2. Pain during rest

    Time frame: 0-26 hours postoperative

    0-100 mm at a visual analogue scale (VAS), at the intervals 2, 4, 8, 24 and 26 hours postoperative, and the area under the curve for the intervals 2-24 and 24-26 hours postoperative.

  3. Pain during 45 degrees active flexion of the knee

    Time frame: 0-26 hours postoperative

    0-100 mm at a visual analogue scale (VAS), at the intervals 2, 4, 8, 24 and 26 hours postoperative, and the area under the curve for the intervals 2-24 and 24-26 hours postoperative.

  4. A change in pain in the placebo group

    Time frame: 24-26 hours postoperative

    0-100 mm at a visual analogue scale (VAS), at the intervals 24 and 26 hours postoperative.

  5. Postoperative nausea

    Time frame: 0-26 hours postoperative

    Nausea scores(0-3)at 2,4,8,24,26 hours postoperative.

  6. Zofran consumption

    Time frame: 0-26 hours postoperative

    Total zofran consumption at the intervals 0-24 and 24-26 hours postoperative.

  7. Sedation

    Time frame: 0-26 hours postoperative

    Seadtion score (0-3) at 2,4,8,24,26 hours postoperative.

  8. Mobilisation

    Time frame: 20-26 hours postoperative

    Number of seconds it takes to complete the "Timed Up and Go" test, at 20 and 26 hours postoperative.

  9. Postoperative vomiting

    Time frame: 0-26 hours postoperative

    Number of vomiting episodes at the intervals 0-2,2-4,4-8,8-24,24-26 hours postoperative.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 16, 2010
Registry last updated
Apr 13, 2011

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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