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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
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 VAS and PROMIS. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post-Operative Non Opioid Pain Protocol | Experimental | Patients will be administered a post-operative non-opioid pain protocol consisting of: Celecoxib Ketorolac Gabapentin Acetaminophen Diazepam |
|
| Post-Operative Traditional Pain Protocol | Active Comparator | Patients will be administered a traditional post-operative pain protocol consisting of: Hydrocodone-acetaminophen 5-325 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celecoxib | Drug | Post-Operative Non Opioid Pain Protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Levels | Patients recorded pain levels 3 times per day using Visual analog scales until study completion. Average daily pain was calculated for each patient. Higher values portend worse control. | 10 days post-operatively |
| Patient-Reported Outcomes Measurement Information System | Patient-Reported Outcomes Measurement Information System Physical Interference (PROMIS PI) nightly until study completion. Average PROMIS PI values calculated nightly. A higher score indicates more pain interference. | 10 days post-operatively |
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Eligibility Criteria:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Toufic R Jildeh, MD | Contact | 517-230-8511 | tjildeh1@hfhs.org |
| Name | Affiliation | Role |
|---|---|---|
| Toufic R Jildeh, MD | Henry Ford Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Health System | Recruiting | Detroit | Michigan | 48202 | United States |
Per request
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 27, 2022 | Feb 16, 2022 | 1 | ||
| Sep 14, 2025 |
| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| C514822 | oxycodone-acetaminophen |
| D020910 | Ketorolac |
| D020911 | Ketorolac Tromethamine |
| D000077206 | Gabapentin |
| D000082 | Acetaminophen |
| D003975 | Diazepam |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Hydrocodone-Acetaminophen | Drug | Traditionally used narcotic pain protocol |
|
|
| Ketorolac | Drug | Post-Operative Non Opioid Pain Protocol |
|
|
| Gabapentin | Drug | Post-Operative Non Opioid Pain Protocol |
|
|
| Acetaminophen | Drug | Post-Operative Non Opioid Pain Protocol |
|
|
| Diazepam | Drug | Post-Operative Non Opioid Pain Protocol |
|
|
| Oct 1, 2025 |
| 2 |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000588 | Amines |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000814 | Aniline Compounds |
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |