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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03111186
Other study ID # HS-15-00706
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date April 24, 2017
Est. completion date May 1, 2019

Study information

Verified date June 2019
Source University of Southern California
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


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Study Design


Intervention

Drug:
Oxycodone Hcl 5Mg
oxycodone HCl 5 mg up to six times daily as needed for pain
Ibuprofen 400 mg
Ibuprofen 400 mg up to six times daily as needed for pain
Acetaminophen 650 mg
Acetaminophen 650 mg up to four times daily as needed for pain

Locations

Country Name City State
United States Keck School of Medicine of the University of Southern California Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

References & Publications (12)

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Outcome

Type Measure Description Time frame Safety issue
Primary change in VAS pain scale Visual Analog Score - pain scale, patient questionnaire baseline, daily - up to 1 week postoperative
Secondary change in Brief Pain Index Brief Pain Index - pain scale, patient questionnaire baseline, daily - up to 1 week postoperative
Secondary change in pain diary Pain Diary - pain scale, patient questionnaire baseline, daily - up to 1 week postoperative
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