A Randomized Trial Comparing Ibuprofen Plus Acetaminophen Versus Oxycodone Alone After Outpatient Soft Tissue Hand Surgery
| Registry | NCT03111186 |
|---|---|
| Status | Completed |
| Phase | Phase 2 |
| Study type | Interventional; randomized, parallel, masking: none, supportive care |
| Enrollment | 40 (Actual) |
| Sponsor | University of Southern California (Other) |
| Conditions | Carpal Tunnel Syndrome, Dupuytren Contracture, Trigger Digit, Ganglion Cysts, De Quervain Disease |
| Interventions | Oxycodone Hcl 5Mg, Ibuprofen 400 mg, Acetaminophen 650 mg (Drug) |
| Dates | start 2017-04-24, primary completion 2019-05-01, completion 2019-05-01, first posted 2017-04-12, last updated 2019-09-26 |
| Locations | 1 site in United States |
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This study is about pain control and medication following outpatient soft-tissue hand surgery. We hope to learn if ibuprofen and acetaminophen will achieve similar pain relief and satisfaction when compared with oxycodone alone.
Opiate analgesics remain the most popular option following outpatient hand surgery despite growing evidence that non-opiate analgesics may provide equivalent pain relief with fewer adverse effects and greater overall satisfaction. The purpose of this randomized trial is to compare the efficacy, side effect profiles and satisfaction associated with Ibuprofen plus Acetaminophen versus Oxycodone alone following outpatient hand surgery. No previous studies have compared the use of opiate analgesics with acetaminophen/ibuprofen following outpatient hand surgery. Patients will be randomized to receive either oxycodone alone or acetaminophen and ibuprofen following outpatient soft tissue hand surgery. Patients will be randomized to receive one of the two aforementioned pain regimens. Patients will be given a booklet in which to record pain level by visual analog scale (VAS), satisfaction with pain control, brief pain inventory and any side effects. Patients will be seen in clinic 1 week after surgery to review symptoms. Patients may also be contacted by phone to review daily log of symptoms. Patients will be seen in clinic 1 week after surgery per standard of care.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Opiate group | Active comparator | Drug: Oxycodone Hcl 5Mg | Group receiving oxycodone alone (oxycodone HCl 5 mg up to six times daily as needed for pain) |
| Non-opiate group | Active comparator | Drug: Ibuprofen 400 mg; Drug: Acetaminophen 650 mg | Group receiving ibuprofen and acetaminophen (acetaminophen 650 mg up to four times daily and ibuprofen 400 mg up to six times daily as need for pain) |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * age greater than 18 years * scheduled to undergo elective outpatient soft tissue hand surgery for one of the following procedures: Carpal tunnel release, Dupuytren contracture release, trigger digit release, ganglion cyst removal, de Quervain's release. * primary language is English or Spanish Exclusion Criteria: * any pre-existing condition requiring preoperative opiate analgesia, eg chronic pain syndrome * allergy to acetaminophen, ibuprofen, or oxycodone * renal impairment or liver disease either documented based on history or when preoperative creatinine, BUN, or liver function tests are outside the normal range provided by the lab * peptic ulcer disease or any history of gastrointestinal bleeding * coagulopathy documented on history, review of systems, or based on preoperative lab testing where PT, PTT, or INR are outside the normal range provided by the lab * pregnancy based on positive beta-HCG test which is performed on the day of the surgical procedure as is standard protocol
| Facility | City | Country | Status |
|---|---|---|---|
| Keck School of Medicine of the University of Southern California | Los Angeles, California | United States |