Anterior Cruciate Ligament RupturePhase 4NCT04285853
Are Opioids Needed After ACL Reconstruction
A Phase 4 study testing Oxycodone in people with Anterior Cruciate Ligament Rupture, run by Emory University at 3 sites in United States.
Trial summary
As the public health sector continues to confront the opioid epidemic, orthopaedic surgeons must revisit pain management protocols to reduce unnecessary opioid prescriptions. The long-term goal is to reduce opioid use and residual opioids in circulation. Read more about this study
- Who is it for?
- Ages 14 to 40 years
- Conditions the study is for
- Anterior Cruciate Ligament Rupture
- What is being tested?
- Oxycodone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 3 sitesUnited States
- Study dates
- 16 Sep 2020to 19 Sep 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 14 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Males and females
- Aged 14-40 years
- Scheduled for primary (Anterior cruciate ligament) ACL reconstruction using quadriceps tendon autograft.
Who cannot join
- Revision and/or contralateral ACL reconstruction procedures
- Allergies to local anesthetics
- Chronic pain medication use
- Weight <50 kg, local infections
- Known coagulopathies,
- Liver dysfunction or renal failure
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The Emory Clinic
Atlanta, Georgia, 30324
Emory clinic at Executive Park
Atlanta, Georgia, 30329
Emory Orthopedic and spine Hospital
Tucker, Georgia, 30084
About this study
Official title: Are Opioids Needed: A Double-Blinded, Randomized Controlled Trial and Examination of Predictors of Opioid Use Following ACL Reconstruction
As the public health sector continues to confront the opioid epidemic, orthopaedic surgeons must revisit pain management protocols to reduce unnecessary opioid prescriptions. The long-term goal is to reduce opioid use and residual opioids in circulation.
Read the detailed description
As the public health sector continues to confront the opioid epidemic, orthopaedic surgeons must revisit pain management protocols to reduce unnecessary opioid prescriptions. The long-term goal is to reduce opioid use and residual opioids in circulation. The purposes are to 1) conduct a double-blinded randomized controlled trial to determine the effectiveness of opioid versus non-opioid medications on post-surgical pain, and 2) examine predictors of opioid usage in individuals following Anterior Cruciate ligament (ACL) reconstruction. Patients will use an innovative Smartphone application to track pain and medication usage. Additionally, patients will complete quality of life and pain catastrophizing questionnaires, as well as undergo pain threshold testing, to be used in a model to determine predictors of greater post-surgical opioid use. This study will provide information on non-opioid alternatives and specific predictors of post-surgical opioid use that can be used to develop prescribing protocols. These findings will help orthopaedic surgeons make informed decisions when tailoring individualized prescriptions for patients following ACL reconstruction. Importantly, findings will be readily translatable into research to reduce opioid use in other orthopaedic surgical cohorts as well. Our ultimate goal is to lessen the burden of the opioid epidemic on not only our orthopaedic patients, but also society, by minimizing the number of opioids left in circulation.
- Conditions
- Anterior Cruciate Ligament Rupture
- Being tested
- Oxycodone, Placebo oral tablet
- Keywords
- Opioids
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxycodoneDrug
Also called Xtampza ER, Oxaydo, Roxicodone, and Oxycontin
5 mg oxycodone pills every 4-6 hrs if pain level 7 or higher on Numeric rating scale 1-10
Placebo oral tabletDrug
Placebo tablets (both trial and "rescue") will be matched to size, shape, color, and texture of oxycodone tablets.
| Study group | Role | What they receive |
|---|---|---|
| Oxycodone Arm | Experimental | Patients in this opioid group will receive 15 oral opioid tablets (5 mg oxycodone) Patients will also receive 8 "rescue" medications, in the Oxycodone arm will be placebo "rescue" medications.
All participants will also receive the following as part of standard of care:
1. Oral non-opioid (1000 mg acetaminophen), every 8 hours.
2. Prescription of non-opioid non-steroidal anti-inflammatory medication (naproxen 500 mg) to be used 2x/day post-surgery.
3. Standardized multimodal intra- and post-operative protocols, including an adductor canal peripheral nerve block.
4. Intraoperative education on post-surgical pain management. Receives: Drug: Oxycodone |
| Placebo Arm | Placebo comparator | Patients in placebo group will receive 15 placebo tablets. All patients will also receive 8 "rescue" medications: Patients who randomize to the non-opioid arm will receive 5mg oxycodone "rescue" tablets.
All participants will also receive the following as part of standard of care:
1. Oral non-opioid (1000 mg acetaminophen), every 8 hours.
2. Prescription of non-opioid non-steroidal anti-inflammatory medication (naproxen 500 mg) to be used 2x/day post-surgery.
3. Standardized multimodal intra- and post-operative protocols, including an adductor canal peripheral nerve block.
4. Intraoperative education on post-surgical pain management. Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Level: Numeric Rating Scale
Patients will record pain levels on Numeric Rating Scale 1-10, where 1 is minimal pain and 10 is associated with highest level of pain (worse outcome).
Measured: Postoperative days 0-6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start16 Sep 2020
- Primary completion19 Sep 2022
- Study completion19 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, double-blind, randomized controlled clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Orthopedic Research and Education Foundation
- Responsible party
- Principal investigator, John Xerogeanes, Emory University
- Investigators
- John Xerogeanes, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04285853
- Sponsor's protocol ID
- IRB00116728
- Status last verified
- Sep 2023
- First submitted
- 24 Feb 2020
- Last updated
- 11 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Opioids Needed: A Double-Blinded, Randomized Controlled Trial and Examination of Predictors of Opioid Use Following ACL Reconstruction
- ClinicalTrials.gov ID
- NCT04285853
- Acronym / sponsor ID
- IRB00116728
- Conditions
- Anterior Cruciate Ligament Rupture
- Keywords
- Opioids
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Orthopedic Research and Education Foundation
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- 19 Sep 2022 (actual)
- Study completion
- 19 Sep 2022 (actual)
- First posted
- 26 Feb 2020 (actual)
- Results
- Posted 11 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
As the public health sector continues to confront the opioid epidemic, orthopaedic surgeons must revisit pain management protocols to reduce unnecessary opioid prescriptions. The long-term goal is to reduce opioid use and residual opioids in circulation.
Detailed description
As the public health sector continues to confront the opioid epidemic, orthopaedic surgeons must revisit pain management protocols to reduce unnecessary opioid prescriptions. The long-term goal is to reduce opioid use and residual opioids in circulation. The purposes are to 1) conduct a double-blinded randomized controlled trial to determine the effectiveness of opioid versus non-opioid medications on post-surgical pain, and 2) examine predictors of opioid usage in individuals following Anterior Cruciate ligament (ACL) reconstruction. Patients will use an innovative Smartphone application to track pain and medication usage. Additionally, patients will complete quality of life and pain catastrophizing questionnaires, as well as undergo pain threshold testing, to be used in a model to determine predictors of greater post-surgical opioid use. This study will provide information on non-opioid alternatives and specific predictors of post-surgical opioid use that can be used to develop prescribing protocols. These findings will help orthopaedic surgeons make informed decisions when tailoring individualized prescriptions for patients following ACL reconstruction. Importantly, findings will be readily translatable into research to reduce opioid use in other orthopaedic surgical cohorts as well. Our ultimate goal is to lessen the burden of the opioid epidemic on not only our orthopaedic patients, but also society, by minimizing the number of opioids left in circulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Prospective, double-blind, randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Oxycodone Arm | Experimental | Drug: OxycodonePatients in this opioid group will receive 15 oral opioid tablets (5 mg oxycodone) Patients will also receive 8 "rescue" medications, in the Oxycodone arm will be placebo "rescue" medications. All participants will also receive the following as part of standard of care: 1. Oral non-opioid (1000 mg acetaminophen), every 8 hours. 2. Prescription of non-opioid non-steroidal anti-inflammatory medication (naproxen 500 mg) to be used 2x/day post-surgery. 3. Standardized multimodal intra- and post-operative protocols, including an adductor canal peripheral nerve block. 4. Intraoperative education on post-surgical pain management. |
| Placebo Arm | Placebo comparator | Drug: Placebo oral tabletPatients in placebo group will receive 15 placebo tablets. All patients will also receive 8 "rescue" medications: Patients who randomize to the non-opioid arm will receive 5mg oxycodone "rescue" tablets. All participants will also receive the following as part of standard of care: 1. Oral non-opioid (1000 mg acetaminophen), every 8 hours. 2. Prescription of non-opioid non-steroidal anti-inflammatory medication (naproxen 500 mg) to be used 2x/day post-surgery. 3. Standardized multimodal intra- and post-operative protocols, including an adductor canal peripheral nerve block. 4. Intraoperative education on post-surgical pain management. |
Who may qualify
- Ages
- 14 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Males and females
- Aged 14-40 years
- Scheduled for primary (Anterior cruciate ligament) ACL reconstruction using quadriceps tendon autograft.
Key exclusion criteria (6 listed)
- Revision and/or contralateral ACL reconstruction procedures
- Allergies to local anesthetics
- Chronic pain medication use
- Weight <50 kg, local infections
- Known coagulopathies,
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 |
|---|---|---|
| OxycodoneAlso: Xtampza ER, Oxaydo, Roxicodone, and Oxycontin5 mg oxycodone pills every 4-6 hrs if pain level 7 or higher on Numeric rating scale 1-10 | Drug | Oxycodone Arm |
| Placebo oral tabletPlacebo tablets (both trial and "rescue") will be matched to size, shape, color, and texture of oxycodone tablets. | Drug | Placebo Arm |
Primary outcome
Pain Level: Numeric Rating Scale
Time frame: Postoperative days 0-6
Patients will record pain levels on Numeric Rating Scale 1-10, where 1 is minimal pain and 10 is associated with highest level of pain (worse outcome).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
John Xerogeanes, MD principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxycodone in people with Anterior Cruciate Ligament Rupture, run by Emory University at 3 sites 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 3 inclusion and 6 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 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain Level: Numeric Rating Scale (time frame: Postoperative days 0-6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Oct 2023.