Opioids Versus Non-Opioids Postoperative After Knee Arthroscopic Surgery
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSanford Health
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects ≥ 18 years of age through ≤ 80 years of age
Subjects undergoing elective arthroscopic knee surgery, to include partial meniscectomy, chondroplasty, or loose body removal.
Disqualifiers
Previously enrolled in this study (enrolled for contralateral knee in this study)
Knee arthroscopy patients scheduled for knee ligament reconstructions
Bilateral knee arthroscopy
History of chronic opioid use or long-term analgesic therapy
Trial design
Design model
Parallel
Treatments tested in this trial
Norco 5Mg-325Mg Tablet
Drug1 tablet up to 4 times per day for 7 days
Ibuprofen 600 mg
Drug1 tablet up to 4 times per day for 7 days
Acetaminophen 325Mg Tab
Drug1 tablet up to 4 times per day for 7 days
Treatment groups
148 Participants
are divided into 2 treatment groupsGroup A: OpioidActive comparator 1 intervention
Group B: Non-opioidActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
Daily for 2 weeks post-operatively2
Change from Baseline Medication Use at 2 weeks
Patients will be asked how many study medication capsules have they taken.
Time frame
Daily for 14 days post-operativelySecondary outcomes
1
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".
Time frame
baseline, 2 weeks, and 6 weeks post-operatively2
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"
Time frame
baseline, 2 weeks, and 6 weeks post-operativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov