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Post-operative Analgesia in Elective, Soft-tissue 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: NCT02029235
Recruitment Status : Terminated (Early termination due to slower than anticipated recruitment.)
First Posted : January 7, 2014
Results First Posted : December 13, 2018
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
Alexander Payatakes, M.D., Milton S. Hershey Medical Center

Brief Summary:
The purpose of this research study is to find out which combination of pain medications following surgery work the best and result in the fewest side effects.

Condition or disease Intervention/treatment Phase
Carpal Tunnel Ganglion Cyst Trigger Finger De Quervain Disease Drug: Acetaminophen/Ibuprofen Drug: Acetaminophen/Hydrocodone Phase 4

Detailed Description:
This is a prospective, randomized, double-blind study comparing the efficacy of acetaminophen/hydrocodone (AH) to acetaminophen/ibuprofen (AIBU) in providing adequate post-operative pain relief in elective, soft tissue hand surgery patients.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Post-operative Analgesia in Elective, Soft-tissue Hand Surgery: A Randomized, Double Blind Comparison of Acetaminophen/Ibuprofen Versus Acetaminophen/Hydrocodone
Actual Study Start Date : February 10, 2015
Actual Primary Completion Date : November 17, 2017
Actual Study Completion Date : June 30, 2018


Arm Intervention/treatment
Active Comparator: Acetaminophen/Ibuprofen (AIBU) Group
Acetaminophen 500 mg and Ibuprofen 400 mg
Drug: Acetaminophen/Ibuprofen
Postoperatively, subjects will be given acetaminophen 500 mg / ibuprofen 400mg every 4 hours, as needed, for one week or until essentially pain-free
Other Names:
  • Acetaminophen/Tylenol
  • Ibuprofen/Advil/Motrin

Active Comparator: Acetaminophen/Hydrocodone (AH) Group
Acetaminophen 325 mg and Hydrocodone 5 mg
Drug: Acetaminophen/Hydrocodone
Postoperatively, subjects will be given acetaminophen 325 mg / hydrocodone 5 mg every 4 hours, as needed, for one week or until essentially pain-free
Other Name: Norco




Primary Outcome Measures :
  1. Efficacy Comparison of Pain Intensity Level [ Time Frame: 1 week post-operatively ]

    Subjects asked to fill out a patient diary recording their pain intensity level (on 100mm Visual Analog Scale) prior to taking study medication every 4 hours.

    The daily average pain intensity levels are reported as a score on a scale of 0-100, with higher score meaning worse outcome.

    The daily average pain levels were assessed daily for 1 week post-operatively, then compared between the 2 groups using a two-group Student's t-test.



Secondary Outcome Measures :
  1. Efficacy Comparison of Pain Relief [ Time Frame: 1 week postoperatively ]

    Subjects asked to fill out a patient diary recording their pain relief (on a Likert scale) one hour after taking study medication every 4 hours.

    Daily average pain relief scores are reported as a score on a scale of 0-3, with higher score meaning better outcome.

    The daily average pain relief scores were assessed daily for 1 week post-operatively, then compared using generalized linear mixed-effects models




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age greater than or equal to 18
  • Male or Female (non-pregnant)
  • Elective, soft tissue hand surgery indicated based on diagnosis made by either clinical exam or diagnostic studies (ie nerve conduction study, EMG) or a combination of the two (carpal tunnel release, trigger finger release, first dorsal compartment release, ganglion cyst excision, second extensor compartment release)
  • Subjects are capable of giving informed consent

Exclusion Criteria:

  • Allergy to study medication
  • Any pre-existing pain condition requiring analgesia
  • Fibromyalgia
  • Recent upper gastrointestinal bleeding
  • Coagulopathy (primary or medication-related)
  • Renal impairment
  • Liver disease
  • Pregnancy
  • Patients who consent to the study but require unexpected admission, including those requiring admission resulting from operative complications, will be excluded before randomization

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): NCT02029235


Locations
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United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Alexander Payatakes, M.D.
Investigators
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Principal Investigator: Alexander Payatakes, M.D. Milton S. Hershey Medical Center
  Study Documents (Full-Text)

Documents provided by Alexander Payatakes, M.D., Milton S. Hershey Medical Center:

Publications:
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Responsible Party: Alexander Payatakes, M.D., Principal Investigator / Sponsor, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT02029235    
Other Study ID Numbers: IRB - 00076
First Posted: January 7, 2014    Key Record Dates
Results First Posted: December 13, 2018
Last Update Posted: December 13, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Alexander Payatakes, M.D., Milton S. Hershey Medical Center:
Adult
soft-tissue hand surgery
Additional relevant MeSH terms:
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Ganglion Cysts
Trigger Finger Disorder
De Quervain Disease
Cysts
Neoplasms
Mucinoses
Connective Tissue Diseases
Tendon Entrapment
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Acetaminophen
Ibuprofen
Acetaminophen, hydrocodone drug combination
Hydrocodone
Oxycodone
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics