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| Name | Class |
|---|---|
| London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | OTHER |
| University of Michigan | OTHER |
| Jefferson Medical College of Thomas Jefferson University | OTHER |
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The purposes of this noninferiority randomized clinical trial are to:
Participants will be provided with forms by site coordinators and will be provided in person instruction on how to fill out the pain intensity scores, the pain interference scores, the pain medication diary, and the final pain relief assessment form.
Medications will be identified only by number and will be available to the participant after standard instruction on use of medications is provided by the surgeon or research associate. Patients will be instructed - verbally and written - to take the study medication (2 capsules per dose) up to four times per day as needed for pain for 1 week or until pain free.
If patients experience intolerable discomfort, they will be able to contact personnel (24 hours on call) associated with the study to receive an alternate analgesic. The surgeon will determine if the patient is taking the maximum dose and then prescribe additional study drug or a non-study drug as an alternative. If the patient receives pain medication outside of the study protocol, the medication will be recorded, this will be recorded as a protocol violation. If this occurs in more than 20 people during the trial a per-protocol and efficacy analysis will be considered.
Participants will return to see the surgeon or designate between post-operative day 7 and 14 to return their diary, unused medication, and post-operative pain satisfaction survey. Participants will be specifically asked about: any adverse events, compliance with the program and the reason for any deviation and any other analgesic medication taken during the course of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Narcotic | Experimental | Hydrocodone + acetaminophen 4 times per day 1 week after surgery |
|
| non-narcotic | Active Comparator | ibuprofen + acetaminophen 4 times per day 1 week after surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Narcotic | Drug | Hydrocodone 5mg + acetaminophen 325 mg |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain relief | 1. Determine whether the most commonly used nonnarcotic analgesics (ibuprofen 600 mg + acetaminophen 325 mg) provide pain relief that is not unacceptably worse than the most commonly prescribed narcotic containing analgesic (hydrocodone 5 mg + acetaminophen 325 mg, equivalent to Norco® 5/325) in patients undergoing carpal tunnel release. | 7-15 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donald Lalonde, MD | Saint John, NB | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Philadelphia Hand Center | Philadelphia | Pennsylvania | 19107 | United States | ||
| Sanford orthopedics and Sports Medicine-Sioux Falls |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35041636 | Background | Lalonde DH, Lalonde JF, MacDermid JC, Chung KC, Gan BS, Mierisch C, Van Demark RE Jr, Luc M. Time to Stop Routinely Prescribing Opiates after Carpal Tunnel Release. Plast Reconstr Surg. 2022 Mar 1;149(3):651-660. doi: 10.1097/PRS.0000000000008834. |
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| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| ID | Term |
|---|---|
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D009294 | Narcotics |
| C514822 | oxycodone-acetaminophen |
| D018712 | Analgesics, Non-Narcotic |
| D007052 | Ibuprofen |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| McGill University | OTHER |
| University of Western Ontario, Canada | OTHER |
| Sanford Health | OTHER |
| Carilion Clinic | OTHER |
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| non-narcotic | Drug | ibuprofen 600mg + acetaminophen 325 mg |
|
|
| Sioux Falls |
| South Dakota |
| 57104 |
| United States |
| CarilionClinic | Roanoke | Virginia | 24014 | United States |
| Horizon Health Network | Saint John | New Brunswick | E2L 4L4 | Canada |
| Lawson Health Research Institute | London | Ontario | N6A 4V2 | Canada |
| University of Western Ontario, Canada | London | Ontario | Canada |
| McGill University | Montreal | Quebec | H3A 0G4 | Canada |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |