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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pia Jaeger, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01191593
First received: August 30, 2010
Last updated: August 21, 2013
Last verified: August 2013
  Purpose
The purpose of this study is to determine whether Adductor-Canal-Blockade is effective at reducing pain and morphine consumption after revision knee arthroplasty.

Condition Intervention Phase
Postoperative Pain Knee Arthroplasty Procedure: Adductor-Canal-Blockade with Ropivacaine Procedure: Adductor-Canal-blockade with saline Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Adductor-Canal-Blockade on Pain and Morphine Consumption After Revision Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by Pia Jaeger, Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Pain during 45 degrees active flexion of the knee [ Time Frame: 4 hours postoperative ]
    0-100 mm at a visual analogue scale (VAS), at 4 hours postoperative.


Secondary Outcome Measures:
  • Pain during 45 degrees active flexion of the knee [ Time Frame: 1-8 hours postoperative ]
    0-100 mm at a visual analogue scale (VAS), registered at the intervals 1, 2, 4, 6 and 8 hours postoperative, calculated as "the area under the curve" (AUC) for the interval 1-8 hours postoperative.

  • Pain during 45 degrees active flexion of the knee [ Time Frame: 24 hours postoperative ]
    0-100 mm at a visual analogue scale (VAS), at 24 hours postoperative.

  • Pain during rest [ Time Frame: 1-8 hours postoperative ]
    0-100 mm at a visual analogue scale (VAS), registered at the intervals 1, 2, 4, 6 and 8 hours postoperative, calculated as "the area under the curve" (AUC) for the interval 1-8 hours postoperative.

  • Pain during rest [ Time Frame: 24 hours postoperative ]
    0-100 mm at a visual analogue scale (VAS), at 24 hours postoperative.

  • Total morphine consumption [ Time Frame: 0-24 hours postoperative ]
    Total morphine consumption at the intervals 0-8, 8-24 and 0-24 hours postoperative.

  • Postoperative nausea [ Time Frame: 1-8 hours postoperative ]
    Nausea scores(0-3)registered at 1,2,4,6 and 8 hours postoperative, calculated as mean value for the interval 1-8 hours postoperative.

  • Postoperative nausea [ Time Frame: 24 hours postoperative ]
    Nausea score(0-3)at 24 hours postoperative.

  • Postoperative vomiting [ Time Frame: 0-24 hours postoperative ]
    Number of vomiting episodes at the intervals 0-8, 8-24 and 0-24 hours postoperative.

  • Zofran consumption [ Time Frame: 0-24 hours postoperative ]
    Total zofran consumption at the intervals 0-8, 8-24 and 0-24 hours postoperative.

  • Sedation [ Time Frame: 1-8 hours postoperative ]
    Sedation score (0-3) registered at 1,2,4,6 and 8 hours postoperative, calculated as the mean value for the interval 1-8 hours postoperative.

  • Sedation [ Time Frame: 24 hours postoperative ]
    Sedation score (0-3) at 24 hours postoperative.


Enrollment: 36
Study Start Date: September 2010
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adductor-Canal-Blockade with ropivacaine Procedure: Adductor-Canal-Blockade with Ropivacaine
US-guided Adductor-Canal-Blockade with ropivacaine 7,5 mg/ml
Other Names:
  • Naropine
  • Postoperative pain
  • US-guided nerve block
Placebo Comparator: Adductor-Canal-blockade with saline Procedure: Adductor-Canal-blockade with saline
US-guided Adductor-Canal-blockade with saline
Other Name: Placebo block

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Revision Knee Arthroplasty in general anaesthesia
  • American society of anesthesiologists (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01191593

Locations
Denmark
Department of Anaesthesia and Surgery, HOC, Rigshospitalet, Denmark
Copenhagen, København Ø, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Pia Jæger, MD Rigshospitalet, Denmark
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pia Jaeger, M.D., Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01191593     History of Changes
Other Study ID Numbers: SM1-PJ-10
2010-021161-71 ( EudraCT Number )
Study First Received: August 30, 2010
Last Updated: August 21, 2013

Keywords provided by Pia Jaeger, Rigshospitalet, Denmark:
Adductor-Canal-Blockade
postoperative pain
US-guided nerve block
revision knee arthroplasty

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Morphine
Ropivacaine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Local
Anesthetics

ClinicalTrials.gov processed this record on July 21, 2017