Use of Local Infiltration Analgesia Following Total Hip Arthroplasty

This study has been completed.
Sponsor:
Collaborator:
Lundbeck Foundation
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01344395
First received: April 9, 2010
Last updated: January 21, 2013
Last verified: January 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    Cummulative morphine comsumption postoperatively


Secondary Outcome Measures:
  • Pain intensity [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: No ]
    Pain intensity measured on the visual analog scale (VAS) at rest and during walking

  • Postoperative nausea [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01344395     History of Changes
Other Study ID Numbers: 2009-016445-25
Study First Received: April 9, 2010
Last Updated: January 21, 2013
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Ropivacaine
Ketorolac
Ketorolac Tromethamine
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
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014