Back to resultsUse of Local Infiltration Analgesia Following Total Hip Arthroplasty
Primary Purpose
Pain, Postoperative, Pain
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
ropivacaine and ketorolac
Ketorolac
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative
Eligibility 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
Sites / Locations
- Aarhus University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
RK-group
K-group
Arm Description
Outcomes
Primary Outcome Measures
Morphine consumption
Cummulative morphine comsumption postoperatively
Secondary Outcome Measures
Pain intensity
Pain intensity measured on the visual analog scale (VAS) at rest and during walking
Postoperative nausea
Number of episodes of nausea measured on a 3 points rating scale (mild, moderate and severe)
Full Information
NCT ID
NCT01344395
First Posted
April 9, 2010
Last Updated
January 21, 2013
Sponsor
University of Aarhus
Collaborators
Lundbeck Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01344395
Brief Title
Use of Local Infiltration Analgesia Following Total Hip Arthroplasty
Official Title
Local Infiltration Analgesia in Total Hip Arthroplasty - Efficacy of Multiple Bolus Injections With Ropivacaine and Ketorolac
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Lundbeck Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RK-group
Arm Type
Experimental
Arm Title
K-group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
ropivacaine and ketorolac
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Intervention Description
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
Primary Outcome Measure Information:
Title
Morphine consumption
Description
Cummulative morphine comsumption postoperatively
Time Frame
24 hours postoperatively
Secondary Outcome Measure Information:
Title
Pain intensity
Description
Pain intensity measured on the visual analog scale (VAS) at rest and during walking
Time Frame
24 hours postoperatively
Title
Postoperative nausea
Description
Number of episodes of nausea measured on a 3 points rating scale (mild, moderate and severe)
Time Frame
24 hours postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kjeld Søballe, Professor
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
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Use of Local Infiltration Analgesia Following Total Hip Arthroplasty
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