CaffeinePhase 3NCT04872270
Pain Management After Shoulder Arthroplasty
A Phase 3 study testing Total Shoulder Arthroplasty, Caffeine Pill and Percocet 10Mg-325Mg Tablet in people with Caffeine and Pain, Joint, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
Pain control is a critical after many surgical procedures. It is well known that orthopaedic surgeries are among the most painful procedures, with total joint arthroplasty being a clear example of this situation. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caffeine, Pain, Joint
- What is being tested?
- Total Shoulder Arthroplasty, Caffeine Pill and Percocet 10Mg-325Mg Tablet
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2021to 15 Apr 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients who undergo primary Total Shoulder Arthroplasty or Reverse Total Shoulder Arthroplasty
- Patient willing and able to complete postoperative surveys
- Post-Menopausal Women and Men over the age of 55
Who cannot join
- Patients reporting caffeine consumption in excess of 300mg daily
- Patient has known history of opioid addiction, has taken opioids preoperatively, or other forms of substance abuse.
- Patient has history of cardiac diseases that might be aggravated by the use of caffeine, as diagnosed by a cardiologist or demonstrated by an abnormal EKG.
- Patient has a known allergy to aspirin or caffeine.
- Patient has history of cancer, neuropathic pain, or nerve degenerative disease that would affect patient reported outcomes including pain.
- Patient has history of anxiety disorder
Show all 11Show fewer
- Patients with known sleep disturbances that would otherwise be affected by caffeine
- Patients undergoing revision surgery
- Patients who require alternate DVT prophylaxis other than ASA.
- Patients undergoing inpatient arthroplasty
- Workman's comp patient or patient has current litigation pending
Trial locations and contacts
1 site in 1 country.
United States1 site
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: Multimodal Postoperative Pain Management Following Shoulder Arthroplasty
Pain control is a critical after many surgical procedures. It is well known that orthopaedic surgeries are among the most painful procedures, with total joint arthroplasty being a clear example of this situation. Current trends in pain management are morphing and multimodal opioid sparing protocols are now being evaluated and implemented, with results showing a decrease in the amount of opioids being prescribed. Despite all efforts, most patients experience pain and, in order to control it, multiple medications have been tried with variable results. The most commonly prescribed medications are opioids, but side effects associated with their use as well as their addictive potential are making them a less desirable option for patients. Currently there is a trend towards diminishing opioids consumption and prescribing alternative pain control regimens.Caffeine is a well known molecule that when associated with non-steroidal anti-inflammatory drugs (NSAIDS) potentiates their analgesic effect and decreases the amount of doses required to control pain. Little is known about the effect of caffeine over pain relief in patients undergoing total joint arthroplasty, but preliminary results in other fields make us believe it could have a potential benefit for patients undergoing total joint arthroplasty.
- Conditions
- Caffeine, Pain, Joint
- Being tested
- Total Shoulder Arthroplasty, Caffeine Pill, Percocet 10Mg-325Mg Tablet, Zofran 4Mg Tablet
- Medical subject headings
- Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Shoulder ArthroplastyProcedure or surgery
Participant will have total shoulder replacement
Caffeine PillDrug
2 week supply of 1000 mg caffeine given postoperatively as part of the pain regimen
Percocet 10Mg-325Mg TabletDrug
given postoperatively as standard post-op pain management
Zofran 4Mg TabletDrug
given postoperatively as standard post-op management
| Study group | Role | What they receive |
|---|---|---|
| Caffeine Group | Active comparator | 2 week supply of 100mg caffeine + aspirin 325mg + standard pain regimen (experimental) Receives: Procedure: Total Shoulder Arthroplasty; Drug: Caffeine Pill; Drug: Percocet 10Mg-325Mg Tablet; Drug: Zofran 4Mg Tablet |
| No Caffeine Group | Active comparator | aspirin 325mg + standard pain (control) Receives: Procedure: Total Shoulder Arthroplasty; Drug: Percocet 10Mg-325Mg Tablet; Drug: Zofran 4Mg Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative shoulder function
This will be measured using the Simple Shoulder Test (SST) which consist of 12 questions
Measured: 24 weeks
Postoperative shoulder function
This will be measured using the American Shoulder and Elbow Surgeon Survey (ASES)
Measured: 24 weeks
Postoperative Pain
This will be measured using the Visual Analog Scale for Pain (VAS) survey
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start15 Apr 2021
- Primary completion15 Apr 2022 (estimated)
- Study completion15 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CaffeineStudies 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
- 160 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
- NCT04872270
- Sponsor's protocol ID
- FTJO21D.060
- Status last verified
- May 2021
- First submitted
- 3 May 2021
- Last updated
- 4 May 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 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Postoperative Pain Management Following Shoulder Arthroplasty
- ClinicalTrials.gov ID
- NCT04872270
- Acronym / sponsor ID
- FTJO21D.060
- Conditions
- Caffeine, Pain, Joint
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 15 Apr 2022 (estimated)
- Study completion
- 15 Apr 2022 (estimated)
- First posted
- 4 May 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.
Pain control is a critical after many surgical procedures. It is well known that orthopaedic surgeries are among the most painful procedures, with total joint arthroplasty being a clear example of this situation. Current trends in pain management are morphing and multimodal opioid sparing protocols are now being evaluated and implemented, with results showing a decrease in the amount of opioids being prescribed. Despite all efforts, most patients experience pain and, in order to control it, multiple medications have been tried with variable results. The most commonly prescribed medications are opioids, but side effects associated with their use as well as their addictive potential are making them a less desirable option for patients. Currently there is a trend towards diminishing opioids consumption and prescribing alternative pain control regimens.Caffeine is a well known molecule that when associated with non-steroidal anti-inflammatory drugs (NSAIDS) potentiates their analgesic effect and decreases the amount of doses required to control pain. Little is known about the effect of caffeine over pain relief in patients undergoing total joint arthroplasty, but preliminary results in other fields make us believe it could have a potential benefit for patients undergoing total joint arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caffeine Group | Active comparator | Procedure: Total Shoulder Arthroplasty, Drug: Caffeine Pill, Drug: Percocet 10Mg-325Mg Tablet, Drug: Zofran 4Mg Tablet2 week supply of 100mg caffeine + aspirin 325mg + standard pain regimen (experimental) |
| No Caffeine Group | Active comparator | Procedure: Total Shoulder Arthroplasty, Drug: Percocet 10Mg-325Mg Tablet, Drug: Zofran 4Mg Tabletaspirin 325mg + standard pain (control) |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients who undergo primary Total Shoulder Arthroplasty or Reverse Total Shoulder Arthroplasty
- Patient willing and able to complete postoperative surveys
- Post-Menopausal Women and Men over the age of 55
Key exclusion criteria (11 listed)
- Patients reporting caffeine consumption in excess of 300mg daily
- Patient has known history of opioid addiction, has taken opioids preoperatively, or other forms of substance abuse.
- Patient has history of cardiac diseases that might be aggravated by the use of caffeine, as diagnosed by a cardiologist or demonstrated by an abnormal EKG.
- Patient has a known allergy to aspirin or caffeine.
- Patient has history of cancer, neuropathic pain, or nerve degenerative disease that would affect patient reported outcomes including 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 |
|---|---|---|
| Total Shoulder ArthroplastyParticipant will have total shoulder replacement | Procedure or surgery | Caffeine Group, No Caffeine Group |
| Caffeine Pill2 week supply of 1000 mg caffeine given postoperatively as part of the pain regimen | Drug | Caffeine Group |
| Percocet 10Mg-325Mg Tabletgiven postoperatively as standard post-op pain management | Drug | Caffeine Group, No Caffeine Group |
| Zofran 4Mg Tabletgiven postoperatively as standard post-op management | Drug | Caffeine Group, No Caffeine Group |
Primary outcome
postoperative shoulder function
Time frame: 24 weeks
This will be measured using the Simple Shoulder Test (SST) which consist of 12 questions
Postoperative shoulder function
Time frame: 24 weeks
This will be measured using the American Shoulder and Elbow Surgeon Survey (ASES)
Postoperative Pain
Time frame: 15 days
This will be measured using the Visual Analog Scale for Pain (VAS) survey
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 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 Total Shoulder Arthroplasty, Caffeine Pill and Percocet 10Mg-325Mg Tablet in people with Caffeine and Pain, Joint, 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 3 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: status not confirmed, as of the sponsor's last update on 4 May 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 shoulder function (time frame: 24 weeks). The study lists 3 primary outcomes in all. 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 4 May 2021; AzTrials last refreshed its copy on 31 Oct 2026.