A Phase 2 interventional study of Oxycodone Hcl 5Mg and Ibuprofen 400 mg in Carpal Tunnel Syndrome, Dupuytren Contracture and Trigger Digit, sponsored by University of Southern California. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-26.
Sponsored by University of Southern California · Phase 2, Interventional, and Supportive care
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.
136 studies on the registry are indexed under Ganglion Cysts; 28 are open to participants now.
This study's enrollment of 40 is below the median of 60 across 101 interventional studies indexed under Ganglion Cysts.
Browse Ganglion Cysts studies →University of Southern California is the lead sponsor of 773 studies on the registry; 135 are open to participants now.
Of its 68 completed or terminated interventional studies of FDA-regulated products, 32 (47%) have results posted.
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Exclusion Criteria:
Group receiving oxycodone alone (oxycodone HCl 5 mg up to six times daily as needed for pain)
Drug: Oxycodone Hcl 5Mg
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 · Drug: Acetaminophen 650 mg
oxycodone HCl 5 mg up to six times daily as needed for pain
Also known as: 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
change in VAS pain scale
Visual Analog Score - pain scale, patient questionnaire
Time frame: baseline, daily - up to 1 week postoperative
change in Brief Pain Index
Brief Pain Index - pain scale, patient questionnaire
Time frame: baseline, daily - up to 1 week postoperative
change in pain diary
Pain Diary - pain scale, patient questionnaire
Time frame: baseline, daily - up to 1 week postoperative
Plan to share: Yes — Data will be shared as required with the USC Health Sciences Institutional Review Board. Participant data will be coded with coding identifiers kept separately by research personnel only and destroyed upon completion of the study.
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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University of Southern California