Keck School of Medicine of the University of Southern California
Los Angeles, California, 90033, United States
NCT Number: NCT03111186
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Los Angeles, California, 90033, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
oxycodone HCl 5 mg up to six times daily as needed for pain
Other names: oxycodone
Ibuprofen 400 mg up to six times daily as needed for pain
Acetaminophen 650 mg up to four times daily as needed for pain
Time frame: baseline, daily - up to 1 week postoperative
Visual Analog Score - pain scale, patient questionnaire
Time frame: baseline, daily - up to 1 week postoperative
Brief Pain Index - pain scale, patient questionnaire
Time frame: baseline, daily - up to 1 week postoperative
Pain Diary - pain scale, patient questionnaire
University of Southern California
Other
A Randomized Trial Comparing Ibuprofen Plus Acetaminophen Versus Oxycodone Alone After Outpatient Soft Tissue Hand Surgery
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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