Osteoarthritis, HipNCT03358888
Prolonged Multimodal Analgesia for Post-Discharge Pain Control After Primary Total Hip Arthroplasty
A study testing Multi-modal with as needed opioids and Multi-modal with one week of opioids offered in people with Osteoarthritis, Hip, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Hip
- What is being tested?
- Multi-modal with as needed opioids and Multi-modal with one week of opioids offered
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2017to 28 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- Sensory/motor disorder involving the operative limb
- Planned or unplanned discharge to rehab
- Length of stay >3 days
- Revision or conversion THA
- Cigarette smokers
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Osteoarthritis, Hip
- Being tested
- Multi-modal with as needed opioids, Multi-modal with one week of opioids offered, Standard of Care
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-modal with as needed opioidsDrug
Multi-modal with as needed oxycodone and tramadol provided for break-through pain
Multi-modal with one week of opioids offeredDrug
Multi-modal with only one week of oxycodone and tramadol provided for emergency pain relief only
Standard of CareDrug
This arm follows standard of care post-operative pain management with oxycodone, tramadol, and acetametophin
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Not described Receives: Drug: Standard of Care |
| Multi-modal with as needed opioids | Active comparator | Not described Receives: Drug: Multi-modal with as needed opioids |
| Multi-modal with one week of opioids offered | Active comparator | Not described Receives: Drug: Multi-modal with one week of opioids offered |
What is being measured
The primary outcome is the main question the study is designed to answer.
total opioid consumption
Measured: total consumption calcuated from surgery date through 30 days post-op
Pain
Pain as reported by Visual Analog Scale
Measured: 30 days post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study start5 Jun 2017
- Primary completion22 Jan 2018
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03358888
- Sponsor's protocol ID
- 2017- Chen
- Status last verified
- Jan 2019
- First submitted
- 27 Nov 2017
- Last updated
- 29 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fleischman AN, Tarabichi M, Foltz C, Makar G, Hozack WJ, Austin MS, Chen AF; Opioid Prescription in Orthopedic Surgery after Discharge Research Group. Cluster-Randomized Trial of Opiate-Sparing Analgesia after Discharge from Elective Hip Surgery. J Am Coll Surg. 2019 Oct;229(4):335-345.e5. doi: 10.1016/j.jamcollsurg.2019.05.026. Epub 2019 Jun 5.
PubMed 31176028
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prolonged Multimodal Analgesia for Post-Discharge Pain Control After Primary Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT03358888
- Acronym / sponsor ID
- 2017- Chen
- Conditions
- Osteoarthritis, Hip
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 5 Jun 2017 (actual)
- Primary completion
- 22 Jan 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 2 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Drug: Standard of Care |
| Multi-modal with as needed opioids | Active comparator | Drug: Multi-modal with as needed opioids |
| Multi-modal with one week of opioids offered | Active comparator | Drug: Multi-modal with one week of opioids offered |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- Opioid use within 3 months prior to surgery
- General anesthesia
- Non-english speaking
- ASA IV or greater
- Allergy/contraindications to protocol medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-modal with as needed opioidsMulti-modal with as needed oxycodone and tramadol provided for break-through pain | Drug | Multi-modal with as needed opioids |
| Multi-modal with one week of opioids offeredMulti-modal with only one week of oxycodone and tramadol provided for emergency pain relief only | Drug | Multi-modal with one week of opioids offered |
| Standard of CareThis arm follows standard of care post-operative pain management with oxycodone, tramadol, and acetametophin | Drug | Standard of Care |
Primary outcome
total opioid consumption
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
- Derived from this study: PubMed 31176028Fleischman AN, Tarabichi M, Foltz C, Makar G, Hozack WJ, Austin MS, Chen AF; Opioid Prescription in Orthopedic Surgery after Discharge Research Group. Cluster-Randomized Trial of Opiate-Sparing Analgesia after Discharge from Elective Hip Surgery. J Am Coll Surg. 2019 Oct;229(4):335-345.e5. doi: 10.1016/j.jamcollsurg.2019.05.026. Epub 2019 Jun 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-modal with as needed opioids and Multi-modal with one week of opioids offered in people with Osteoarthritis, Hip, run by Rothman Institute Orthopaedics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total opioid consumption (time frame: total consumption calcuated from surgery date through 30 days post-op). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03358888, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2019.