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Trial record 2 of 4 for:    Ibuprofen acetaminophen hand surgery

Ibuprofen Plus Acetaminophen Versus Oxycodone Alone After Hand Surgery

This study is not yet open for participant recruitment.
Verified May 2017 by Alidad Ghiassi, University of Southern California
Sponsor:
ClinicalTrials.gov Identifier:
NCT03111186
First Posted: April 12, 2017
Last Update Posted: May 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Alidad Ghiassi, University of Southern California
  Purpose
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.

Condition Intervention Phase
Carpal Tunnel Syndrome Dupuytren Contracture Trigger Digit Ganglion Cysts De Quervain Disease Drug: Oxycodone Hcl 5Mg Drug: Ibuprofen 400 mg Drug: Acetaminophen 650 mg Phase 2

Study Type: Interventional
Study Design: 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
Official Title: A Randomized Trial Comparing Ibuprofen Plus Acetaminophen Versus Oxycodone Alone After Outpatient Soft Tissue Hand Surgery

Resource links provided by NLM:


Further study details as provided by Alidad Ghiassi, University of Southern California:

Primary Outcome Measures:
  • change in VAS pain scale [ Time Frame: baseline, daily - up to 1 week postoperative ]
    Visual Analog Score - pain scale, patient questionnaire


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 168
Anticipated Study Start Date: June 5, 2017
Estimated Study Completion Date: December 31, 2017
Estimated Primary Completion Date: October 31, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Opiate group
Group receiving oxycodone alone (oxycodone HCl 5 mg up to six times daily as needed for pain)
Drug: Oxycodone Hcl 5Mg
oxycodone HCl 5 mg up to six times daily as needed for pain
Other Name: oxycodone
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)
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03111186


Contacts
Contact: Alidad Ghiassi, MD 323-442-5860 ghiassi1@gmail.com
Contact: Keemia Soraya Heidari, BA 323-442-5860 kheidar@usc.edu

Locations
United States, California
Keck School of Medicine of the University of Southern California Not yet recruiting
Los Angeles, California, United States, 90033
Contact: Keemia Soraya Heidari, BA         
Principal Investigator: Alidad Ghiassi, MD         
Sub-Investigator: Milan Stevanovic, MD         
Sub-Investigator: Brock Foster, MD         
Sub-Investigator: Daniel Lorenzana, BS         
Sub-Investigator: Keemia Soraya Heidari, BA         
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: Alidad Ghiassi, MD University of Southern California
  More Information

Publications:

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: HS-15-00706
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: HS-15-00706

Responsible Party: Alidad Ghiassi, Assistant Professor of Clinical Orthopaedic Surgery, University of Southern California
ClinicalTrials.gov Identifier: NCT03111186     History of Changes
Other Study ID Numbers: HS-15-00706
First Submitted: April 6, 2017
First Posted: April 12, 2017
Last Update Posted: May 11, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
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.

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

Keywords provided by Alidad Ghiassi, University of Southern California:
oxycodone
ibuprofen
acetaminophen
soft-tissue hand surgery
carpal tunnel release
Dupuytren contracture release
Trigger digit release
Ganglion cyst removal
De Quervain's release

Additional relevant MeSH terms:
Acetaminophen
Ibuprofen
Carpal Tunnel Syndrome
Ganglion Cysts
Synovial Cyst
Contracture
Dupuytren Contracture
Trigger Finger Disorder
De Quervain Disease
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Cysts
Neoplasms
Mucinoses
Connective Tissue Diseases
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Fibroma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type