Clinical trial NCT03111186: Ibuprofen Plus Acetaminophen Versus Oxycodone Alone After Hand Surgery
Official title: A Randomized Trial Comparing Ibuprofen Plus Acetaminophen Versus Oxycodone Alone After Outpatient Soft Tissue Hand Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carpal Tunnel Syndrome
Dupuytren Contracture
Trigger Digit
Ganglion Cysts
De Quervain Disease
Keywords: oxycodone
ibuprofen
acetaminophen
soft-tissue hand surgery
carpal tunnel release
Dupuytren contracture release
Trigger digit release
Ganglion cyst removal
De Quervain's release
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2017-04-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: change in VAS pain scale
timeFrame: baseline, daily - up to 1 week postoperative
Secondary outcomes:
measure: change in Brief Pain Index
timeFrame: baseline, daily - up to 1 week postoperative
measure: change in pain diary
timeFrame: baseline, daily - up to 1 week postoperative
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Keck School of Medicine of the University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Alidad Ghiassi, MD
role: PRINCIPAL_INVESTIGATOR
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