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Use of Local Infiltration Analgesia Following Total Hip Arthroplasty

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01344395
First Posted: April 29, 2011
Last Update Posted: January 23, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Lundbeck Foundation
Information provided by (Responsible Party):
University of Aarhus
  Purpose
The primary aim of this study is to evaluate if multiple postoperative administrations with a solution of ropivacaine, ketorolac and epinephrine into the operating field through a catheter would affect morphine consumption. Secondary end-points are pain intensity, side effects and length of stay.

Condition Intervention Phase
Pain, Postoperative Pain Drug: ropivacaine and ketorolac Drug: Ketorolac Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Local Infiltration Analgesia in Total Hip Arthroplasty - Efficacy of Multiple Bolus Injections With Ropivacaine and Ketorolac

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Morphine consumption [ Time Frame: 24 hours postoperatively ]
    Cummulative morphine comsumption postoperatively


Secondary Outcome Measures:
  • Pain intensity [ Time Frame: 24 hours postoperatively ]
    Pain intensity measured on the visual analog scale (VAS) at rest and during walking

  • Postoperative nausea [ Time Frame: 24 hours postoperatively ]
    Number of episodes of nausea measured on a 3 points rating scale (mild, moderate and severe)


Enrollment: 80
Study Start Date: March 2010
Study Completion Date: September 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RK-group Drug: ropivacaine and ketorolac
The RK-group receives four intra-articular injections via catheter with a total volume of 40 ml (380 mg ropivacaine and 60 mg ketorolac) combined with 4 intravenous injections of saline during 24 hours postoperatively
Active Comparator: K-group Drug: Ketorolac
The K-group receives four intra-articular injections via catheter with a total volume of 40 ml saline combined with 4 intravenous injections of ketorolac (total 60 mg) during 24 hours postoperatively

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled for total hip arthroplasty
  • Patients > 18 years of age
  • Signed written informed consent
  • Spinal anaesthesia

Exclusion Criteria:

  • Allergy towards study drugs
  • Rheumatoid arthritis
  • Body Mass Index > 35 (severe obesity)
  • Pregnancy or nursing women
  • Regular opioid use
  • Patients who can not read or understand danish
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01344395


Locations
Denmark
Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Lundbeck Foundation
Investigators
Principal Investigator: Kjeld Søballe, Professor Aarhus University Hospital
  More Information

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01344395     History of Changes
Other Study ID Numbers: 2009-016445-25
First Submitted: April 9, 2010
First Posted: April 29, 2011
Last Update Posted: January 23, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Ropivacaine
Ketorolac
Ketorolac Tromethamine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action