Pain, PostoperativePhase 3NCT05154682
Pain Management After Surgery
A Phase 3 study testing OxyCODONE 5 mg Oral Tablet, Acetaminophen 500Mg Tab and Naproxen 500 Mg in people with Pain, Postoperative, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
Following outpatient orthopaedic surgery, adequate pain control is imperative both for patient satisfaction and for improved recovery and rehabilitation. Opioids are frequently utilized for postoperative pain control, however they can be addictive and are known to have many deleterious effects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- OxyCODONE 5 mg Oral Tablet, Acetaminophen 500Mg Tab and Naproxen 500 Mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2021to 30 Nov 2022
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- undergoing elective outpatient orthopaedic surgery under general anesthesia.
Who cannot join
- Age < 18 years old
- Non-English speaking
- allergy to or medical contraindication to taking oxycodone (or other opioids), acetaminophen, or Naprosyn (or other NSAIDs).
- currently taking opioid medications
- history of chronic opioid therapy for chronic pain
- surgery being performed under local anesthesia only, without general anesthesia or sedation
Trial locations and contacts
1 site in 1 country.
United States1 site
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: Multi-Modal Pain Management After Outpatient Orthopaedic Surgery: A Prospective Randomized Trial
Following outpatient orthopaedic surgery, adequate pain control is imperative both for patient satisfaction and for improved recovery and rehabilitation. Opioids are frequently utilized for postoperative pain control, however they can be addictive and are known to have many deleterious effects. Recent studies have demonstrated the effectiveness of a wide variety of multi-modal postoperative pain regimens in providing adequate pain control while also decreasing opioid usage. However, the most effective multi-modal pain regimen for postoperative pain control remains unclear. This prospective, randomized study intends to investigate the efficacy of a multi-modal postoperative pain regimen compared to a traditional opioid-only pain regimen following elective outpatient orthopaedic surgery of the hand, wrist, foot, or ankle.
- Conditions
- Pain, Postoperative
- Being tested
- OxyCODONE 5 mg Oral Tablet, Acetaminophen 500Mg Tab, Naproxen 500 Mg
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxyCODONE 5 mg Oral TabletDrug
Oxycodone will be given every 4 hours as needed for 2 weeks after surgery
Acetaminophen 500Mg TabDrug
Acetaminophen will be taken every 4 hours for 2 weeks after surgery
Naproxen 500 MgDrug
Naproxen will be taken every 12 hours for 2 weeks after surgery
| Study group | Role | What they receive |
|---|---|---|
| Oxycodone Group (Control Group) | Active comparator | Patients will receive oxycodone as needed after surgery Receives: Drug: OxyCODONE 5 mg Oral Tablet |
| Oxycodone+ Naproxen/Acetaminophen (Study Group) | Active comparator | each patient will receive oxycodone plus acetaminophen and naproxen for 2 weeks after surgery Receives: Drug: OxyCODONE 5 mg Oral Tablet; Drug: Acetaminophen 500Mg Tab; Drug: Naproxen 500 Mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain
With the use of an 11 point numeric rating scale (NRS) daily satisfaction with their pain regimen, patients pain level and medication usage will be recorded.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start30 Nov 2021
- Primary completion30 Nov 2022 (estimated)
- Study completion30 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05154682
- Sponsor's protocol ID
- AILY 21D.615
- Status last verified
- Nov 2021
- First submitted
- 30 Nov 2021
- Last updated
- 13 Dec 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Modal Pain Management After Outpatient Orthopaedic Surgery: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT05154682
- Acronym / sponsor ID
- AILY 21D.615
- Conditions
- Pain, Postoperative
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 13 Dec 2021 (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.
Following outpatient orthopaedic surgery, adequate pain control is imperative both for patient satisfaction and for improved recovery and rehabilitation. Opioids are frequently utilized for postoperative pain control, however they can be addictive and are known to have many deleterious effects. Recent studies have demonstrated the effectiveness of a wide variety of multi-modal postoperative pain regimens in providing adequate pain control while also decreasing opioid usage. However, the most effective multi-modal pain regimen for postoperative pain control remains unclear. This prospective, randomized study intends to investigate the efficacy of a multi-modal postoperative pain regimen compared to a traditional opioid-only pain regimen following elective outpatient orthopaedic surgery of the hand, wrist, foot, or ankle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxycodone Group (Control Group) | Active comparator | Drug: OxyCODONE 5 mg Oral TabletPatients will receive oxycodone as needed after surgery |
| Oxycodone+ Naproxen/Acetaminophen (Study Group) | Active comparator | Drug: OxyCODONE 5 mg Oral Tablet, Drug: Acetaminophen 500Mg Tab, Drug: Naproxen 500 Mgeach patient will receive oxycodone plus acetaminophen and naproxen for 2 weeks after surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years old
- undergoing elective outpatient orthopaedic surgery under general anesthesia.
Key exclusion criteria (6 listed)
- Age < 18 years old
- Non-English speaking
- allergy to or medical contraindication to taking oxycodone (or other opioids), acetaminophen, or Naprosyn (or other NSAIDs).
- currently taking opioid medications
- history of chronic opioid therapy for chronic pain
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 |
|---|---|---|
| OxyCODONE 5 mg Oral TabletOxycodone will be given every 4 hours as needed for 2 weeks after surgery | Drug | Oxycodone Group (Control Group), Oxycodone+ Naproxen/Acetaminophen (Study Group) |
| Acetaminophen 500Mg TabAcetaminophen will be taken every 4 hours for 2 weeks after surgery | Drug | Oxycodone+ Naproxen/Acetaminophen (Study Group) |
| Naproxen 500 MgNaproxen will be taken every 12 hours for 2 weeks after surgery | Drug | Oxycodone+ Naproxen/Acetaminophen (Study Group) |
Primary outcome
Postoperative Pain
Time frame: 14 days
With the use of an 11 point numeric rating scale (NRS) daily satisfaction with their pain regimen, patients pain level and medication usage will be recorded.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2021.
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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 Phase 3 study testing OxyCODONE 5 mg Oral Tablet, Acetaminophen 500Mg Tab and Naproxen 500 Mg in people with Pain, Postoperative, 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 2 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: status not confirmed, as of the sponsor's last update on 13 Dec 2021. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Postoperative Pain (time frame: 14 days). 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 13 Dec 2021.