Shoulder SurgeryNCT04294680
Opiate Sparing Versus Opiate Based Following Shoulder Arthroplasty
A study testing Cryotherapy in people with Shoulder Surgery, run by Campbell Clinic at 1 site in United States.
Trial summary
To investigate the difference between an opiate sparing pain management protocol versus a standard opiate-based protocol following shoulder arthroplasty in the ninety day postoperative period regarding visual analog scores and oral morphine equivalents. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Shoulder Surgery
- What is being tested?
- Cryotherapy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 31 May 2021
- Phase
- Interventional
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary shoulder arthroplasty
- 18-85 years of age
- Body Mass Index greater than or equal to 45
- Willing and able to provide written informed consent
- Willing and able to cooperative in the required postoperative therapy
- Willing and able to complete scheduled follow-up evaluations
- Fluent in verbal and written English
Who cannot join
- Less than 18 years or over 85 years of age
- Unable to provide written informed consent, cooperate with postoperative therapy, or complete follow-up evaluations
- Known sensitivity, allergy, or intolerance to medications with protocols
- Renal disease as defined by active or impending dialysis within six months or kidney transplant
- Concomitant ipsilateral upper extremity injury or condition other than shoulder that compromises function
- Chronic pain syndrome
Show all 9Show fewer
- Five consecutive days of opiate use with the previous ninety days
- Worker's compensation claim
- Women who are pregnant, planning to become to become pregnant, or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Randomized, Controlled Trial of an Opiate Sparing Protocol Versus Standard Opiate-Based Protocol Following Shoulder Arthroplasty
To investigate the difference between an opiate sparing pain management protocol versus a standard opiate-based protocol following shoulder arthroplasty in the ninety day postoperative period regarding visual analog scores and oral morphine equivalents.
Read the detailed description
This is a single center, investigator initiated, prospective, randomized, controlled trial conducted among patients who have given voluntary consent to participate. Participation will last until the completion of the twelve weeks standard of care follow up visit.
- Conditions
- Shoulder Surgery
- Being tested
- Cryotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryotherapyDevice
see opiate sparing description
| Study group | Role | What they receive |
|---|---|---|
| Opiate Sparing | Experimental | Cryotherapy one hour daily four times per day for two weeks postoperative Acetaminophen 1000 milligrams every six hours by mouth for fourteen days postoperative Gabapentin 100 milligrams three times per day by mouth for thirty days postoperative Celecoxib 100 milligrams two times per day by mouth for thirty days postoperative Esomeproazole 20 milligrams daily by mouth for thirty days postoperative Ondansetron 4 milligrams every eight hours by mouth as needed for nausea and/or vomiting for fourteen days postoperative Oxycodone 5 milligrams every six hours by mouth as needed for uncontrolled pain for fourteen days postoperative Receives: Device: Cryotherapy |
| Opiate Based | No intervention | Oxycodone 5 to 10 milligrams every four to six hours by mouth as needed for pain for fourteen days postoperative Acetaminophen 1000 milligrams every six hours by mouth for fourteen days postoperative Gabapentin 100 milligrams three times per day by mouth for thirty days postoperative Celecoxib 100 milligrams two times per day by mouth for thirty days postoperative Esomeprazole 20 milligrams daily by mouth for thirty days postoperative Ondansetron 4 milligrams every eight hours by mouth as needed for nausea and/or vomiting for fourteen days postoperative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Score (VAS) at Week 2
The Visual Analog Score (VAS) is a a validated patient reported pain score with possible range from zero (no pain) to ten (worst possible pain).
Measured: postoperative day fourteen (two weeks)
Secondary outcomes (1)
Number of Opioid Pain Pills Taken
The total number of opioid pain pills consumed from post-operative day 1 to Week 12
Measured: Post-operative Day 1 through 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start1 Aug 2019
- Primary completion31 May 2021
- Study completion31 May 2021
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 Shoulder SurgeryStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Campbell Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tyler J. Brolin, Campbell Clinic
- Investigators
- Tyler Brolin, MD, Principal investigator, Campbell Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04294680
- Sponsor's protocol ID
- BMH 19-29
- Status last verified
- Nov 2022
- First submitted
- 27 Feb 2020
- Last updated
- 6 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Controlled Trial of an Opiate Sparing Protocol Versus Standard Opiate-Based Protocol Following Shoulder Arthroplasty
- ClinicalTrials.gov ID
- NCT04294680
- Acronym / sponsor ID
- BMH 19-29
- Conditions
- Shoulder Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Campbell ClinicUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 4 Mar 2020 (actual)
- Results
- Posted 6 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the difference between an opiate sparing pain management protocol versus a standard opiate-based protocol following shoulder arthroplasty in the ninety day postoperative period regarding visual analog scores and oral morphine equivalents.
Detailed description
This is a single center, investigator initiated, prospective, randomized, controlled trial conducted among patients who have given voluntary consent to participate. Participation will last until the completion of the twelve weeks standard of care follow up visit.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opiate Sparing | Experimental | Device: CryotherapyCryotherapy one hour daily four times per day for two weeks postoperative Acetaminophen 1000 milligrams every six hours by mouth for fourteen days postoperative Gabapentin 100 milligrams three times per day by mouth for thirty days postoperative Celecoxib 100 milligrams two times per day by mouth for thirty days postoperative Esomeproazole 20 milligrams daily by mouth for thirty days postoperative Ondansetron 4 milligrams every eight hours by mouth as needed for nausea and/or vomiting for fourteen days postoperative Oxycodone 5 milligrams every six hours by mouth as needed for uncontrolled pain for fourteen days postoperative |
| Opiate Based | No intervention | –Oxycodone 5 to 10 milligrams every four to six hours by mouth as needed for pain for fourteen days postoperative Acetaminophen 1000 milligrams every six hours by mouth for fourteen days postoperative Gabapentin 100 milligrams three times per day by mouth for thirty days postoperative Celecoxib 100 milligrams two times per day by mouth for thirty days postoperative Esomeprazole 20 milligrams daily by mouth for thirty days postoperative Ondansetron 4 milligrams every eight hours by mouth as needed for nausea and/or vomiting for fourteen days postoperative |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Primary shoulder arthroplasty
- 18-85 years of age
- Body Mass Index greater than or equal to 45
- Willing and able to provide written informed consent
- Willing and able to cooperative in the required postoperative therapy
Key exclusion criteria (9 listed)
- Less than 18 years or over 85 years of age
- Unable to provide written informed consent, cooperate with postoperative therapy, or complete follow-up evaluations
- Known sensitivity, allergy, or intolerance to medications with protocols
- Renal disease as defined by active or impending dialysis within six months or kidney transplant
- Concomitant ipsilateral upper extremity injury or condition other than shoulder that compromises function
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 |
|---|---|---|
| Cryotherapysee opiate sparing description | Device | Opiate Sparing |
Primary outcome
Visual Analog Score (VAS) at Week 2
Time frame: postoperative day fourteen (two weeks)
The Visual Analog Score (VAS) is a a validated patient reported pain score with possible range from zero (no pain) to ten (worst possible pain).
1 secondary outcome
Number of Opioid Pain Pills Taken
Time frame: Post-operative Day 1 through 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
- 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.
Tyler Brolin, MD principal investigator
Campbell Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryotherapy in people with Shoulder Surgery, run by Campbell Clinic 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 7 inclusion and 9 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 6 Dec 2022. 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?
Yes. Results are posted in the registry (first posted 6 Dec 2022). 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?
Visual Analog Score (VAS) at Week 2 (time frame: postoperative day fourteen (two weeks)). 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 6 Dec 2022.