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
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 9, 2010
CompletedFirst Posted
Study publicly available on registry
April 29, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedJanuary 23, 2013
January 1, 2013
1.3 years
April 9, 2010
January 21, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Morphine consumption
Cummulative morphine comsumption postoperatively
24 hours postoperatively
Secondary Outcomes (2)
Pain intensity
24 hours postoperatively
Postoperative nausea
24 hours postoperatively
Study Arms (2)
RK-group
EXPERIMENTALK-group
ACTIVE COMPARATORInterventions
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
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 Criteria
You may qualify if:
- Patients scheduled for total hip arthroplasty
- Patients \> 18 years of age
- Signed written informed consent
- Spinal anaesthesia
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- Lundbeck Foundationcollaborator
Study Sites (1)
Aarhus University Hospital
Aarhus, 8000, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kjeld Søballe, Professor
Aarhus University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2010
First Posted
April 29, 2011
Study Start
March 1, 2010
Primary Completion
June 1, 2011
Study Completion
September 1, 2011
Last Updated
January 23, 2013
Record last verified: 2013-01