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NCT Number: NCT01261897

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

The objective of this study is to assess the efficacy of Adductor-Canal-Blockade on pain and morphine consumption after total knee arthroplasty. Our hypothesis is that the Adductor -Canal-Blockade is superior to placebo in reducing pain and morphine consumption after total knee arthroplasty.

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Key information

Conditions

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

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Anaesthesia-Surgery-Intensive Care, Gentofte Hospital

Gentofte Municipality, Hellerup, 2900, Denmark

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Total Knee Arthroplasty in general 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

Treatment and study plan

Adductor-Canal-Blockade with Ropivacaine

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: Sham block

Primary outcomes

  1. Pain during 45 degrees active flexion of the knee

    Time frame: 1 hour postoperative

    0-100 mm at a visual analogue scale (VAS), at 1 hour postoperative

Secondary outcomes

  1. Pain during 45 degrees active flexion of the knee

    Time frame: 0-6 hours postoperative

    0-100 mm at a visual analogue scale (VAS), registered at the intervals 1, 2, 3, 4, 5 and 6 hours postoperative, calculated as "the area under the curve" (AUC) for the interval 1-6 hours postoperative.

  2. Pain during rest

    Time frame: 1-6 hours postoperative

    0-100 mm at a visual analogue scale (VAS), registered at the intervals 1, 2, 3, 4, 5 and 6 hours postoperative, calculated as "the area under the curve" (AUC) for the interval 1-6 hours postoperative.

  3. A change in pain score in the ropivacaine group, after activating the block

    Time frame: 30-60 minutes postoperative

    0-100 mm at a visual analogue scale (VAS), at 30 and 60 minutes postoperative. A change in pain score in the ropivacaine group compared to the placebo group, after activating the block.

  4. Total morphine consumption

    Time frame: 30 minutes - 6 hours postoperative

    Total morphine consumption at the interval 30 minutes - 6 hours postoperative.

  5. Postoperative nausea

    Time frame: 1-6 hours postoperative

    Nausea scores(0-3)registered at 1, 2, 3, 4, 5 and 6 hours postoperative, calculated as mean value for the interval 1-6 hours postoperative.

  6. Postoperative vomiting

    Time frame: 1-6 hours postoperative

    Number of vomiting episodes at the interval 1-6 hours postoperative.

  7. Zofran consumption

    Time frame: 1-6 hours postoperative

    Total zofran consumption at the intervals 1-6 hours postoperative.

  8. Sedation

    Time frame: 1-6 hours postoperative

    Sedation score (0-3) registered at 1, 2, 3, 4, 5 and 6 hours postoperative, calculated as the mean value for the interval 1-6 hours postoperative.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Dec 17, 2010
Registry last updated
Oct 4, 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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