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Prospective Pain Study Comparing Different Treatments After Hand Surgery

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03597308
Recruitment Status : Completed
First Posted : July 24, 2018
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

Tracking Information
First Submitted Date  ICMJE July 12, 2018
First Posted Date  ICMJE July 24, 2018
Last Update Posted Date July 24, 2018
Actual Study Start Date  ICMJE March 17, 2017
Actual Primary Completion Date July 14, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2018)
Numeric rating Scale for Pain [ Time Frame: 2 weeks post-op ]
11-point numeric rating scale (NRS) for pain
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prospective Pain Study Comparing Different Treatments After Hand Surgery
Official Title  ICMJE PROSPECTIVE RANDOMIZED CONTROLLED TRIAL COMPARING OXYCODONE, IBUPROFEN AND ACETAMINOPHEN AFTER WIDE AWAKE HAND SURGERY
Brief Summary The purpose of the study is to evaluate the efficacy of three different types of pain medication (Oxycodone - an opioid, Ibuprofen - a non-steroidal anti-inflammatory, and Acetaminophen - a non-opioid analgesic) in the management of postoperative pain following single soft tissue procedures of the hand and wrist performed exclusively under local anesthesia without sedation. The results of this study will help define optimal prescribing guidelines following the two most common hand surgeries while also potentially validating the use of opioid alternatives post-operatively in order to help mitigate excessive or unnecessary dispensal of opioid analgesics.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Post-operative Pain
Intervention  ICMJE
  • Drug: 5mg of Oxycodone every 6 hours as needed for pain
    5mg of Oxycodone every 6 hours as needed for pain
  • Drug: 600mg of Ibuprofen every 6 hours as needed for pain
    600mg of Ibuprofen every 6 hours as needed for pain
  • Drug: 500mg of Acetaminophen every 6 hours as needed for pain
    500mg of Acetaminophen every 6 hours as needed for pain
Study Arms  ICMJE
  • Active Comparator: Opioid Group
    Intervention: Drug: 5mg of Oxycodone every 6 hours as needed for pain
  • Active Comparator: NSAID group
    Intervention: Drug: 600mg of Ibuprofen every 6 hours as needed for pain
  • Active Comparator: Acetaminophen
    Intervention: Drug: 500mg of Acetaminophen every 6 hours as needed for pain
Publications * Not Provided

*   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: July 12, 2018)
210
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 1, 2017
Actual Primary Completion Date July 14, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  1. Patients indicated to undergo primary, unilateral carpal tunnel release or trigger finger release surgery under local anesthesia alone.
  2. Age eligibility is > 18 years of age.
  3. Local anesthesia with 1% lidocaine with 1:100,000 epinephrine and Bicarbonate.

Exclusion Criteria

  1. Bilateral procedures.
  2. Additional soft tissue or boney procedures performed simultaneously.
  3. The use of sedation and/or general anesthesia.
  4. Pediatric patients (age < 18 years).
  5. Pregnant female patients.
  6. Non-English speaking patients.
  7. Known allergies or medical contraindications to Oxycodone, Ibuprofen, Acetaminophen.
  8. History of chronic pain and/or narcotic use preoperatively.
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 NCT03597308
Other Study ID Numbers  ICMJE 2018Ilyas
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rothman Institute Orthopaedics
Study Sponsor  ICMJE Rothman Institute Orthopaedics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Rothman Institute Orthopaedics
Verification Date July 2018

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