Rotator Cuff TearPhase 2NCT03818919
Nonopioid Analgesia After Rotator Cuff Repair
A Phase 2 study testing Celecoxib, Ketorolac and Gabapentin in people with Rotator Cuff Tear, run by Henry Ford Health System at 1 site in United States.
Trial summary
This is a randomized, single blinded, standard of care controlled clinical trial. This project aims to compare postoperative pain control in patients in two treatment arms of rotator cuff repair: a treatment group given a nonopioid pain control regimen, and a standard of care control group given standard opioid pain… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Celecoxib, Ketorolac and Gabapentin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2019to 31 Dec 2020
- Phase
- Phase 2
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All adult patients over age 18 and scheduled for a primary or revision rotator cuff repair
Who cannot join
- Exclusion criteria will include patients with a medical history of known allergies or intolerance to allergies or intolerance to Celebrex, Tylenol, Neurontin, dexamethasone, tramadol, substantial alcohol or drug abuse, and pregnancy, history of narcotics within 6 months of surgery, renal impairment, peptic ulcer disease, GI bleeding. Secondary exclusion criterion is an intact rotator cuff
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Traditional vs. Nonopioid Analgesia After Rotator Cuff Repair
This is a randomized, single blinded, standard of care controlled clinical trial. This project aims to compare postoperative pain control in patients in two treatment arms of rotator cuff repair: a treatment group given a nonopioid pain control regimen, and a standard of care control group given standard opioid pain control regimen
Read the detailed description
Study Design: This is a randomized, single blinded, standard of care-controlled clinical trial. All adult patients over eighteen desiring rotator cuff repair will be eligible. Nonnarcotic postoperative pain control regimen described below were chosen based on previous studies in fracture care and joint arthroplasty.
Patients will be consented and recruited. Once participation has been determined and consent obtained, the names of participating patients will be provided to the research pharmacy. Patients will be randomized with a computer-generated table in 2 patient blocks by the research pharmacy. Patients postoperative analgesia will be divided into one of the following 2 treatment arms: 1) A novel nonopioid pain protocol or 2) traditional narcotic pain analgesia
Primary endpoints is reduction in pain as measured by visual analogue scale and Patient-Reported Outcomes Measurement Information System. The endpoints will be collected at each post-operative day using a journal. Moreover, endpoints will be collected at the patient's first post-operative appointment. These appointments are scheduled within one-week of the index procedure.
Statistical Analysis: All continuous data will be analyzed using independent 2-group t tests and reported as means ± standard deviations. Categorical data will be compared between the 2 groups using chi-square tests and reported as counts and percentages. A preliminary test to confirm the quality of variances will be conducted prior to utilizing the t test to confirm the appropriate statistical analysis. Nonparametric equivalents Wilcoxon rank-sum and Fisher exact tests will be used as needed for nonnormal distributions and low variable numbers, respectively. A multivariable regression analysis was performed to assess for potential confounding demographic variables.
- Conditions
- Rotator Cuff Tear
- Being tested
- Celecoxib, Ketorolac, Gabapentin, Acetaminophen, Diazepam
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
Also called Celebrex
Post-Operative Non Opioid Pain Protocol
KetorolacDrug
Also called Tylenol
Post-Operative Non Opioid Pain Protocol
GabapentinDrug
Also called Neurontin
Post-Operative Non Opioid Pain Protocol
AcetaminophenDrug
Also called Tylenol
Post-Operative Non Opioid Pain Protocol
DiazepamDrug
Also called Valium
Post-Operative Non Opioid Pain Protocol
Hydrocodone-AcetaminophenDrug
Also called Norco
Traditionally used narcotic pain protocol
| Study group | Role | What they receive |
|---|---|---|
| Post-Operative Non Opioid Pain Protocol | Experimental | Patients in this group will be administered a novel multimodal pain protocol post-operatively consisting of: Celecoxib, Ketorolac, Gabapentin, Acetaminophen, Diazepam Receives: Drug: Celecoxib; Drug: Ketorolac; Drug: Gabapentin; Drug: Acetaminophen; Drug: Diazepam |
| Post-Operative Traditional Pain Protocol | Active comparator | Patients will be administered a traditional post-operative pain protocol consisting of: Hydrocodone-Acetaminophen Cap 5-500 Receives: Drug: Hydrocodone-Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Levels
Patients record pain levels using Visual analog scales for 10 days post-operatively. The visual analog scale ranges from 0 (no pain) to 10 (worst pain). Average daily pain was calculated for each patient. Higher values portend worse control.
Measured: day 10 post-operative
Patient-Reported Outcomes Measurement Information System
Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS PI) for 10 days post-operatively. PROMIS-PI scale ranges from 0 (no pain interference ) to 100 (most pain interference). Average PROMIS PI values were calculated. A higher score indicates more pain interference.
Measured: day 10 post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start22 Jan 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
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 Rotator Cuff TearStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vasilios Moutzouros, Henry Ford Health System
- Investigators
- Toufic R Jildeh, MD, Principal investigator, Resident
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03818919
- Sponsor's protocol ID
- 123191
- Status last verified
- Mar 2024
- First submitted
- 22 Jan 2019
- Last updated
- 2 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Per Request
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traditional vs. Nonopioid Analgesia After Rotator Cuff Repair
- ClinicalTrials.gov ID
- NCT03818919
- Acronym / sponsor ID
- 123191
- Conditions
- Rotator Cuff Tear
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 22 Jan 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 28 Jan 2019 (actual)
- Results
- Posted 2 Apr 2024
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 randomized, single blinded, standard of care controlled clinical trial. This project aims to compare postoperative pain control in patients in two treatment arms of rotator cuff repair: a treatment group given a nonopioid pain control regimen, and a standard of care control group given standard opioid pain control regimen
Detailed description
Study Design: This is a randomized, single blinded, standard of care-controlled clinical trial. All adult patients over eighteen desiring rotator cuff repair will be eligible. Nonnarcotic postoperative pain control regimen described below were chosen based on previous studies in fracture care and joint arthroplasty.
Patients will be consented and recruited. Once participation has been determined and consent obtained, the names of participating patients will be provided to the research pharmacy. Patients will be randomized with a computer-generated table in 2 patient blocks by the research pharmacy. Patients postoperative analgesia will be divided into one of the following 2 treatment arms: 1) A novel nonopioid pain protocol or 2) traditional narcotic pain analgesia
Primary endpoints is reduction in pain as measured by visual analogue scale and Patient-Reported Outcomes Measurement Information System. The endpoints will be collected at each post-operative day using a journal. Moreover, endpoints will be collected at the patient's first post-operative appointment. These appointments are scheduled within one-week of the index procedure.
Statistical Analysis: All continuous data will be analyzed using independent 2-group t tests and reported as means ± standard deviations. Categorical data will be compared between the 2 groups using chi-square tests and reported as counts and percentages. A preliminary test to confirm the quality of variances will be conducted prior to utilizing the t test to confirm the appropriate statistical analysis. Nonparametric equivalents Wilcoxon rank-sum and Fisher exact tests will be used as needed for nonnormal distributions and low variable numbers, respectively. A multivariable regression analysis was performed to assess for potential confounding demographic variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-Operative Non Opioid Pain Protocol | Experimental | Drug: Celecoxib, Drug: Ketorolac, Drug: Gabapentin, Drug: Acetaminophen, Drug: DiazepamPatients in this group will be administered a novel multimodal pain protocol post-operatively consisting of: Celecoxib, Ketorolac, Gabapentin, Acetaminophen, Diazepam |
| Post-Operative Traditional Pain Protocol | Active comparator | Drug: Hydrocodone-AcetaminophenPatients will be administered a traditional post-operative pain protocol consisting of: Hydrocodone-Acetaminophen Cap 5-500 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients over age 18 and scheduled for a primary or revision rotator cuff repair
Key exclusion criteria (1 listed)
- Exclusion criteria will include patients with a medical history of known allergies or intolerance to allergies or intolerance to Celebrex, Tylenol, Neurontin, dexamethasone, tramadol, substantial alcohol or drug abuse, and pregnancy, history of narcotics within 6 months of surgery, renal impairment, peptic ulcer disease, GI bleeding. Secondary exclusion criterion is an intact rotator cuff
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 |
|---|---|---|
| CelecoxibAlso: CelebrexPost-Operative Non Opioid Pain Protocol | Drug | Post-Operative Non Opioid Pain Protocol |
| KetorolacAlso: TylenolPost-Operative Non Opioid Pain Protocol | Drug | Post-Operative Non Opioid Pain Protocol |
| GabapentinAlso: NeurontinPost-Operative Non Opioid Pain Protocol | Drug | Post-Operative Non Opioid Pain Protocol |
| AcetaminophenAlso: TylenolPost-Operative Non Opioid Pain Protocol | Drug | Post-Operative Non Opioid Pain Protocol |
| DiazepamAlso: ValiumPost-Operative Non Opioid Pain Protocol | Drug | Post-Operative Non Opioid Pain Protocol |
| Hydrocodone-AcetaminophenAlso: NorcoTraditionally used narcotic pain protocol | Drug | Post-Operative Traditional Pain Protocol |
Primary outcome
Pain Levels
Time frame: day 10 post-operative
Patients record pain levels using Visual analog scales for 10 days post-operatively. The visual analog scale ranges from 0 (no pain) to 10 (worst pain). Average daily pain was calculated for each patient. Higher values portend worse control.
Patient-Reported Outcomes Measurement Information System
Time frame: day 10 post-operative
Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS PI) for 10 days post-operatively. PROMIS-PI scale ranges from 0 (no pain interference ) to 100 (most pain interference). Average PROMIS PI values were calculated. A higher score indicates more pain interference.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. Per Request
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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.
Toufic R Jildeh, MD principal investigator
Resident
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Celecoxib, Ketorolac and Gabapentin in people with Rotator Cuff Tear, run by Henry Ford Health System 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 1 inclusion and 1 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 2 Apr 2024. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 2 Apr 2024). 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 Levels (time frame: day 10 post-operative). 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?
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 2 Apr 2024.