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Ibuprofen Plus Acetaminophen Versus Oxycodone Alone After Hand Surgery

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ClinicalTrials.gov Identifier: NCT03111186
Recruitment Status : Completed
First Posted : April 12, 2017
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Alidad Ghiassi, University of Southern California

Tracking Information
First Submitted Date  ICMJE April 6, 2017
First Posted Date  ICMJE April 12, 2017
Last Update Posted Date September 26, 2019
Actual Study Start Date  ICMJE April 24, 2017
Actual Primary Completion Date May 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2017)
change in VAS pain scale [ Time Frame: baseline, daily - up to 1 week postoperative ]
Visual Analog Score - pain scale, patient questionnaire
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2017)
  • change in Brief Pain Index [ Time Frame: baseline, daily - up to 1 week postoperative ]
    Brief Pain Index - pain scale, patient questionnaire
  • change in pain diary [ Time Frame: baseline, daily - up to 1 week postoperative ]
    Pain Diary - pain scale, patient questionnaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ibuprofen Plus Acetaminophen Versus Oxycodone Alone After Hand Surgery
Official Title  ICMJE A Randomized Trial Comparing Ibuprofen Plus Acetaminophen Versus Oxycodone Alone After Outpatient Soft Tissue Hand Surgery
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Carpal Tunnel Syndrome
  • Dupuytren Contracture
  • Trigger Digit
  • Ganglion Cysts
  • De Quervain Disease
Intervention  ICMJE
  • Drug: Oxycodone Hcl 5Mg
    oxycodone HCl 5 mg up to six times daily as needed for pain
    Other Name: oxycodone
  • Drug: Ibuprofen 400 mg
    Ibuprofen 400 mg up to six times daily as needed for pain
  • Drug: Acetaminophen 650 mg
    Acetaminophen 650 mg up to four times daily as needed for pain
Study Arms  ICMJE
  • Active Comparator: Opiate group
    Group receiving oxycodone alone (oxycodone HCl 5 mg up to six times daily as needed for pain)
    Intervention: Drug: Oxycodone Hcl 5Mg
  • Active Comparator: Non-opiate group
    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)
    Interventions:
    • Drug: Ibuprofen 400 mg
    • Drug: Acetaminophen 650 mg
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 24, 2019)
40
Original Estimated Enrollment  ICMJE
 (submitted: April 6, 2017)
168
Actual Study Completion Date  ICMJE May 1, 2019
Actual Primary Completion Date May 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03111186
Other Study ID Numbers  ICMJE HS-15-00706
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: 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.
Responsible Party Alidad Ghiassi, University of Southern California
Study Sponsor  ICMJE University of Southern California
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alidad Ghiassi, MD University of Southern California
PRS Account University of Southern California
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP