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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03858231
Other study ID # SH Opioid Knee
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date October 29, 2018
Est. completion date January 2026

Study information

Verified date February 2024
Source Sanford Health
Contact Amy Tuchscherer
Phone (701) 417-6292
Email amy.tuchscherer@sanfordhealth.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 148
Est. completion date January 2026
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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. Documented or suspected chronic pain syndrome 7. Any known allergy or adverse reaction or contraindication to the components of hydrocodone, acetaminophen, or ibuprofen 8. History or symptoms of any significant medical problem in the last year (i.e., arrhythmia, impaired cardiovascular function, gastrointestinal bleeding, liver disease, renal disease) 9. With active peptic ulcer disease (history of severe heartburn) 10. Symptoms of infection with initial enrollment 11. Pregnant or nursing 12. Diagnosis of cognitive impairment 13. Unable or unwilling to provide informed consent for surgery or enrollment in this clinical study 14. 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. 15. Patient refusal 16. Currently taking Coumadin, Plavix, anticoagulation medications, or medications that increase bleeding, with the exception of ASA 81mg. 17. Patients with other medical or psychological health conditions that preclude them from either receiving the intervention or returning for follow-up visits. 18. Alcoholism

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Norco 5Mg-325Mg Tablet
1 tablet up to 4 times per day for 7 days
Ibuprofen 600 mg
1 tablet up to 4 times per day for 7 days
Acetaminophen 325Mg Tab
1 tablet up to 4 times per day for 7 days

Locations

Country Name City State
United States Sanford Health Fargo North Dakota

Sponsors (1)

Lead Sponsor Collaborator
Sanford Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline Pain Assessment at 2 weeks Visual Analog Scale from 0 to 10 with 0 being no pain and 10 being worst possible, unbearable, excruciating pain Daily for 2 weeks post-operatively
Primary Change from Baseline Medication Use at 2 weeks Patients will be asked how many study medication capsules have they taken. Daily for 14 days post-operatively
Secondary Change from Baseline Knee Injury and Osteoarthritis Outcome Score (KOOS) at 6 weeks 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". baseline, 2 weeks, and 6 weeks post-operatively
Secondary Change from Baseline Patient Reported Outcome Measurement Information System (PROMIS) at 6 weeks 7 qualitative questions related to pain interference with responses ranging from "not at all" to "very much" baseline, 2 weeks, and 6 weeks post-operatively
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