- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02186795
Total Hip Arthroplasty Outcomes With Regional and Multimodal Analgesia (THA)
December 19, 2018 updated by: Sylvia Wilson, Medical University of South Carolina
Improvement in Total Hip Arthroplasty Patient Outcomes With Regional Anesthesia and Multimodal Analgesia: A Retrospective Analysis
The goal of this retrospective chart review is to evaluate if the implementation of lumbar plexus block placement for postoperative pain and administration of multimodal oral analgesia have improved conditions in the postoperative period for patients undergoing total hip arthroplasty when compared to the placement of epidurals for postoperative pain management.
Study Overview
Status
Completed
Conditions
Detailed Description
Primary outcome: 48 hour opiate consumption in patients following THA.
' Secondary outcome: Time to first ambulation, assitstance needed with ambulation, opiate and regional related side effects, time to discharge orders.
Study Type
Observational
Enrollment (Actual)
117
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients undergoing primary total hip arthroplasty
Description
Inclusion Criteria:
- Primary total hip arthroplasty, (identified by current procedural terminology (CPT) code 27130) and
Either a) Epidural or b) Lumbar plexus peripheral nerve block with the administration of multimodal medication after July 2012.
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Exclusion Criteria:Exclusion criteria include THA Revision, ICU admission postoperatively, and dementia, not allowing pain score communication.
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Lumbar plexus
Patients received a preoperative lumbar plexus nerve block (20 ml, ropivacaine 0.5%) for postoperative pain management with one to four multimodal oral pain medications (acetaminophen, celecoxib, oxycodone ER, gabapentin, pregabalin) administered preoperatively or in the first 48 hours postoperatively.
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Lumbar Epidural
Patients received a lumbar epidural preoperatively for postoperative pain management.
Epidural infusions of ropivacaine 0.2% were initiated intraoperatively, administered until the morning of postoperative day 1, and titrated to patient comfort.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Opiate Consumption
Time Frame: 48 hours postoperative
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Cumulative 48 Hours Opiate Consumption in Intravenous (IV) Morphine mg Equivalents (MME)
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48 hours postoperative
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sylvia Wilson, M.D., Medical University of South Carolina
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (Actual)
March 1, 2014
Study Completion (Actual)
March 1, 2014
Study Registration Dates
First Submitted
July 3, 2014
First Submitted That Met QC Criteria
July 8, 2014
First Posted (Estimate)
July 10, 2014
Study Record Updates
Last Update Posted (Actual)
March 22, 2019
Last Update Submitted That Met QC Criteria
December 19, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- THA Retrospective Analysis
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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