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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

April 9, 2010
January 21, 2013
March 2010
June 2011   (final data collection date for primary outcome measure)
Morphine consumption [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: No ]
Cummulative morphine comsumption postoperatively
Same as current
Complete list of historical versions of study NCT01344395 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
Not Provided
Not Provided
 
Use of Local Infiltration Analgesia Following Total Hip Arthroplasty
Local Infiltration Analgesia in Total Hip Arthroplasty - Efficacy of Multiple Bolus Injections With Ropivacaine and Ketorolac

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Pain, Postoperative
  • Pain
  • 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
  • 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
  • Experimental: RK-group
    Intervention: Drug: ropivacaine and ketorolac
  • Active Comparator: K-group
    Intervention: Drug: Ketorolac
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
September 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01344395
2009-016445-25
Yes
University of Aarhus
University of Aarhus
Lundbeck Foundation
Principal Investigator: Kjeld Søballe, Professor Aarhus University Hospital
University of Aarhus
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP