Ibuprofen Plus Acetaminophen Versus Oxycodone Alone After Hand Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Trial Comparing Ibuprofen Plus Acetaminophen Versus Oxycodone Alone After Outpatient Soft Tissue Hand Surgery

Conditions
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Carpal Tunnel Syndrome, Dupuytren Contracture, Trigger Digit, Ganglion Cysts, De Quervain Disease

Intervention / Treatment
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* Drug: Oxycodone Hcl 5Mg
* Drug: Ibuprofen 400 mg
* Drug: Acetaminophen 650 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients of either sex, greater than 18 years of age, 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, whose primary language is English or Spanish
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Opiate group<br>Group receiving oxycodone alone (oxycodone HCl 5 mg up to six times daily as needed for pain) | Drug: Oxycodone Hcl 5Mg<br>* oxycodone HCl 5 mg up to six times daily as needed for pain<br>* Other names: oxycodone;|
| Active Comparator: Non-opiate group<br>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) | Drug: Ibuprofen 400 mg<br>* Ibuprofen 400 mg up to six times daily as needed for pain<br>Drug: Acetaminophen 650 mg<br>* Acetaminophen 650 mg up to four times daily as needed for pain<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in VAS pain scale | Visual Analog Score - pain scale, patient questionnaire | baseline, daily - up to 1 week postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Brief Pain Index | Brief Pain Index - pain scale, patient questionnaire | baseline, daily - up to 1 week postoperative | 
| change in pain diary | Pain Diary - pain scale, patient questionnaire | baseline, daily - up to 1 week postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oxycodone, ibuprofen, acetaminophen, soft-tissue hand surgery, carpal tunnel release, Dupuytren contracture release, Trigger digit release, Ganglion cyst removal, De Quervain's release