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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pia Jaeger, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01261897
First received: December 16, 2010
Last updated: October 3, 2011
Last verified: October 2011
  Purpose

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.


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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Adductor-Canal-Blockade on Pain and Morphine Consumption After Total Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Pain during 45 degrees active flexion of the knee [ Time Frame: 1 hour postoperative ] [ Designated as safety issue: No ]
    0-100 mm at a visual analogue scale (VAS), at 1 hour postoperative


Secondary Outcome Measures:
  • Pain during 45 degrees active flexion of the knee [ Time Frame: 0-6 hours postoperative ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Total morphine consumption at the interval 30 minutes - 6 hours postoperative.

  • Postoperative nausea [ Time Frame: 1-6 hours postoperative ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Number of vomiting episodes at the interval 1-6 hours postoperative.

  • Zofran consumption [ Time Frame: 1-6 hours postoperative ] [ Designated as safety issue: No ]
    Total zofran consumption at the intervals 1-6 hours postoperative.

  • Sedation [ Time Frame: 1-6 hours postoperative ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: January 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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: Sham block

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01261897

Locations
Denmark
Department of Anaesthesia-Surgery-Intensive Care, Gentofte Hospital
Gentofte, Hellerup, Denmark, 2900
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Pia Jæger, MD Rigshospitalet, Denmark
  More Information

No publications provided by Rigshospitalet, Denmark

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pia Jaeger, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01261897     History of Changes
Other Study ID Numbers: SM2-PJ-10, 2010-021918-30
Study First Received: December 16, 2010
Last Updated: October 3, 2011
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency

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

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014