- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03358888
Prolonged Multimodal Analgesia for Post-Discharge Pain Control After Primary Total Hip Arthroplasty
January 25, 2019 updated by: Rothman Institute Orthopaedics
This is a prospective, three-arm, comparative study with a provider-crossover design.
The first arm will comprise the standard of care pain regimen after discharge, which comprises PRN oxycodone, tramadol, and acetaminophen.
The second arm will comprise a multimodal pain regimen; however, patients will still be routinely provided PRN oxycodone and tramadol to use on an as needed basis.
The third arm will comprise a multimodal pain management protocol, which does not routinely allow for opioid consumption.
However, patients will be provided a one week supply of oxycodone and tramadol for emergency pain relief only.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
228
Phase
- Not Applicable
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
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Rothman Institute
-
-
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
Description
Inclusion Criteria:
- Patients undergoing unilateral, primary cementless THA with underlying diagnosis of osteoarthritis.
- ASA I - III
- Spinal anesthesia
- Male and Female over 18 who are willing and able to provide informed consent
Exclusion Criteria:
- Opioid use within 3 months prior to surgery
- General anesthesia
- Non-english speaking
- ASA IV or greater
- Allergy/contraindications to protocol medications
- Renal insufficiency with Cr > 2.0 or hepatic failure
- Sensory/motor disorder involving the operative limb
- Planned or unplanned discharge to rehab
- Length of stay >3 days
- Revision or conversion THA
- Cigarette smokers
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
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard of Care
|
This arm follows standard of care post-operative pain management with oxycodone, tramadol, and acetametophin
|
Active Comparator: Multi-modal with as needed opioids
|
Multi-modal with as needed oxycodone and tramadol provided for break-through pain
|
Active Comparator: Multi-modal with one week of opioids offered
|
Multi-modal with only one week of oxycodone and tramadol provided for emergency pain relief only
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
total opioid consumption
Time Frame: total consumption calcuated from surgery date through 30 days post-op
|
total consumption calcuated from surgery date through 30 days post-op
|
|
Pain
Time Frame: 30 days post-operative
|
Pain as reported by Visual Analog Scale
|
30 days post-operative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (Actual)
June 5, 2017
Primary Completion (Actual)
January 22, 2018
Study Completion (Actual)
February 28, 2018
Study Registration Dates
First Submitted
November 27, 2017
First Submitted That Met QC Criteria
November 27, 2017
First Posted (Actual)
December 2, 2017
Study Record Updates
Last Update Posted (Actual)
January 29, 2019
Last Update Submitted That Met QC Criteria
January 25, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017- Chen
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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