Carpal Tunnel Syndrome, Dupuytren Contracture, Trigger Digit, Ganglion Cysts, De Quervain Disease
Conditions
Keywords
oxycodone, ibuprofen, acetaminophen, soft-tissue hand surgery, carpal tunnel release, Dupuytren contracture release, Trigger digit release, Ganglion cyst removal, De Quervain's release
Brief 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.
Detailed 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.
Interventions
DRUGOxycodone Hcl 5Mg
oxycodone HCl 5 mg up to six times daily as needed for pain
DRUGIbuprofen 400 mg
Ibuprofen 400 mg up to six times daily as needed for pain
Acetaminophen 650 mg up to four times daily as needed for pain
Sponsors
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in VAS pain scale | baseline, daily - up to 1 week postoperative | Visual Analog Score - pain scale, patient questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in Brief Pain Index | baseline, daily - up to 1 week postoperative | Brief Pain Index - pain scale, patient questionnaire |
| change in pain diary | baseline, daily - up to 1 week postoperative | Pain Diary - pain scale, patient questionnaire |
Countries
United States
Outcome results
None listed