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This study is a double-blind, randomized controlled trial comparing the effectiveness of oral acetaminophen, diclofenac, and tramadol in reducing the consumption of narcotic doses (primary outcome) and minimizing patients' exposure to narcotics (secondary outcome) following an ultrasound-guided percutaneous needle tenotomy procedure on the lateral elbow.
Tramadol is currently the standard post-procedure medication. Acetaminophen will be prescribed (1000 mg) and should be taken every 8 hours if pain is present. Tylenol should be the first taken for pain. If pain persist, the study kit containing the blinded, pain-controlled capsules will be taken second. Both diclofenac potassium (50mg) and tramadol (50mg) will be provided in identical-looking capsules and randomly assigned to patients in sealed packets by a physician, ensuring the double-blind nature of the study and be instructed to use every 8 hours as needed for pain If pain is still not adequately controlled an hour after taking the blinded study pack, a rescue medication, consisting of tramadol 50mg capsules, will also be supplied to the NSAID group in sealed packets while rescue medication of oral diclofenac will be provided to the opioid group. These medications will be administered immediately after the tenotomy procedure to all participants. The primary endpoint of the study will be the total count of tramadol doses taken by each group at the 10 day (± 4 days) postoperative follow-up. Pill counts from sealed packages and the use of rescue narcotics will be verified during the in-person visit at 10 days (± 4 days) .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diclofenac | Active Comparator | 50mg |
|
| Tramadol | Active Comparator | 50mg |
|
| Acetaminophen | Sham Comparator | 1000mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diclofenac | Drug | 50mg every 8hours as needed for pain |
| |
| Tramadol |
| Measure | Description | Time Frame |
|---|---|---|
| Number of pills taken | The number of total Tramadol pills taken per patient between the control (Tramadol + Diclofenac rescue) vs experimental (Diclofenac + Tramadol rescue) groups at two weeks. | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Non narcotic use | The percentage of patients randomized to Diclofenac that do not use any narcotic (Tramadol) rescue medication | 10 days |
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Inclusion Criteria:
Exclusion Criteria:
• Any full thickness common extensor tendon tear of the elbow
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erin Clancy, BA | Contact | 2169706796 | clancye@ccf.org | |
| Jennifer Baldwin | Contact | 216-390-5833 | baldwij3@ccf.org |
| Name | Affiliation | Role |
|---|---|---|
| Michael Dakkak, DO | Cleveland Clinic Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Cleveland Clinic Florida | Recruiting | Coral Springs | Florida | 33067 | United States |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004008 | Diclofenac |
| D014147 | Tramadol |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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This study is a double-blind, randomized controlled trial comparing the effectiveness of oral acetaminophen, diclofenac, and tramadol in reducing the consumption of narcotic doses (primary outcome) and minimizing patients' exposure to narcotics (secondary outcome) following an ultrasound-guided percutaneous needle tenotomy procedure on the lateral elbow.
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| Drug |
50mg every 8hours as needed for pain |
|
| Acetaminophen | Other | 1000mg every 8hours as needed for pain |
|
| The Cleveland Clinic Ohio | Recruiting | Avon | Ohio | 44011 | United States |
|
| D003511 |
| Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |