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Opioids Versus Non-Opioids Postoperative After Knee Arthroscopic 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03858231
Recruitment Status : Recruiting
First Posted : February 28, 2019
Last Update Posted : January 28, 2020
Sponsor:
Information provided by (Responsible Party):
Sanford Health

Study Description
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Brief Summary:
The purpose of this study is to look at pain management with opioids versus non-opioids after knee arthroscopy. This study will determine 1) whether the most commonly used non-narcotic medications provide pain relief comparable with the most commonly prescribed narcotic medications in patients undergoing arthroscopic knee surgery, and 2) whether patients' characteristics (gender, pre-operative knee symptoms, workers compensation status and employment status) affect pain level following surgery or medication usage.

Condition or disease Intervention/treatment Phase
Knee Injuries Pain, Postoperative Opioid Use Drug: Norco 5Mg-325Mg Tablet Drug: Ibuprofen 600 mg Drug: Acetaminophen 325Mg Tab Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Combination Therapy of Opioids Versus Non-Opioids on Postoperative Pain Management After Knee Arthroscopic Surgery: A Prospective Randomized Controlled Study
Actual Study Start Date : October 29, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : January 2021
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Opioid Drug: Norco 5Mg-325Mg Tablet
1 tablet up to 4 times per day for 7 days
Active Comparator: Non-opioid Drug: Ibuprofen 600 mg
1 tablet up to 4 times per day for 7 days

Drug: Acetaminophen 325Mg Tab
1 tablet up to 4 times per day for 7 days


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline Pain Assessment at 2 weeks [ Time Frame: Daily for 2 weeks post-operatively ]
    Visual Analog Scale from 0 to 10 with 0 being no pain and 10 being worst possible, unbearable, excruciating pain

  2. Change from Baseline Medication Use at 2 weeks [ Time Frame: Daily for 14 days post-operatively ]
    Patients will be asked how many study medication capsules have they taken.


Secondary Outcome Measures :
  1. Change from Baseline Knee Injury and Osteoarthritis Outcome Score (KOOS) at 6 weeks [ Time Frame: baseline, 2 weeks, and 6 weeks post-operatively ]
    Sub-scales are listed as follows: 5 qualitative questions related to knee symptoms ranging from "never" to "always", 2 qualitative questions related to knee stiffness ranging from "none" to "extreme", 9 qualitative questions related to pain ranging from "none" to "extreme", 17 qualitative questions related to function and daily living ranging from "none" to "extreme", 5 qualitative questions related to function and sports and recreational activities ranging from "none" to "extreme", and 4 qualitative questions related to quality of life ranging from "never or not at all" to "constantly, totally, or extreme".

  2. Change from Baseline Patient Reported Outcome Measurement Information System (PROMIS) at 6 weeks [ Time Frame: baseline, 2 weeks, and 6 weeks post-operatively ]
    7 qualitative questions related to pain interference with responses ranging from "not at all" to "very much"


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects ≥ 18 years of age through ≤ 80 years of age
  2. Subjects undergoing elective arthroscopic knee surgery, to include partial meniscectomy, chondroplasty, or loose body removal.

Exclusion Criteria:

  1. Previously enrolled in this study (enrolled for contralateral knee in this study)
  2. Knee arthroscopy patients scheduled for knee ligament reconstructions
  3. Bilateral knee arthroscopy
  4. History of chronic opioid use or long-term analgesic therapy
  5. Documented or suspected substance abuse
  6. Currently on daily use of ibuprofen, acetaminophen or other pain altering medication, including medications like Neurontin (gabapentin) and Ultram (tramadol)
  7. Documented or suspected chronic pain syndrome
  8. Any known allergy or adverse reaction or contraindication to the components of hydrocodone, acetaminophen, or ibuprofen
  9. History or symptoms of any significant medical problem in the last year (i.e., arrhythmia, impaired cardiovascular function, gastrointestinal bleeding, liver disease, renal disease)
  10. With active peptic ulcer disease (history of severe heartburn)
  11. Symptoms of infection with initial enrollment
  12. Pregnant or nursing
  13. Diagnosis of cognitive impairment
  14. Unable or unwilling to provide informed consent for surgery or enrollment in this clinical study
  15. Inability to understand the requirements of the study or be unwilling to provide written informed consent (as evidenced by signature on an informed consent document approved by Institutional Review Board) and agree to abide by the study restrictions.
  16. Patient refusal
  17. Currently taking Coumadin, Plavix, anticoagulation medications, or medications that increase bleeding
  18. Patients with other medical or psychological health conditions that preclude them from either receiving the intervention or returning for follow-up visits.
  19. Alcoholism
Contacts and Locations
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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): NCT03858231


Contacts
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Contact: Amy Tuchscherer (701) 417-6292 amy.tuchscherer@sanfordhealth.org
Contact: Katie Jensen (605) 312-6983 Katie.E.Jensen@SanfordHealth.org

Locations
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United States, North Dakota
Sanford Health Recruiting
Fargo, North Dakota, United States, 58122
Contact: Amy Tuchscherer    701-417-6292    amy.tuchscherer@sanfordhealth.org   
Contact: Katie Jensen    (605) 312-6983    Katie.E.Jensen@SanfordHealth.org   
Principal Investigator: Bruce Piatt, MD         
Sponsors and Collaborators
Sanford Health
Investigators
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Principal Investigator: Bruce Piatt, MD Sanford Health
More Information
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Responsible Party: Sanford Health
ClinicalTrials.gov Identifier: NCT03858231    
Other Study ID Numbers: SH Opioid Knee
First Posted: February 28, 2019    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020

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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
Additional relevant MeSH terms:
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Pain, Postoperative
Knee Injuries
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Leg Injuries
Wounds and Injuries
Acetaminophen
Ibuprofen
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