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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 2011

Interventions

  • Procedure: Adductor-Canal-Blockade with Ropivacaine
    • US-guided Adductor-Canal-Blockade with ropivacaine 7,5 mg/ml
  • Procedure: Adductor-Canal-blockade with saline
    • US-guided Adductor-Canal-blockade with saline

Arms, Groups and Cohorts

  • Active Comparator: Adductor-Canal-Blockade with Ropivacaine
  • Placebo Comparator: Adductor-Canal-blockade with saline

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.
  • 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.
  • 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.
  • Total morphine consumption
    • Time Frame: 30 minutes – 6 hours postoperative
    • Total morphine consumption at the interval 30 minutes – 6 hours postoperative.
  • 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.
  • Postoperative vomiting
    • Time Frame: 1-6 hours postoperative
    • Number of vomiting episodes at the interval 1-6 hours postoperative.
  • Zofran consumption
    • Time Frame: 1-6 hours postoperative
    • Total zofran consumption at the intervals 1-6 hours postoperative.
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rigshospitalet, Denmark
  • Provider of Information About this Clinical Study
    • Principal Investigator: Pia Jaeger, MD – Rigshospitalet, Denmark
  • Overall Official(s)
    • Pia Jæger, MD, Principal Investigator, Rigshospitalet, Denmark

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