Opioids Versus Non-Opioids Postoperative After Knee Arthroscopic Surgery

The Effects of Combination Therapy of Opioids Versus Non-Opioids on Postoperative Pain Management After Knee Arthroscopic Surgery: A Prospective Randomized Controlled Study

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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative; Knee Injuries; Opioid Use
• Intervention / Treatment: Drug: Norco 5Mg-325Mg Tablet; Drug: Ibuprofen 600 mg; Drug: Acetaminophen 325Mg Tab

• Study Type: Interventional
• Enrollment (Estimated): 148
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Amy Tuchscherer; Phone Number: (701) 417-6292; Email: amy.tuchscherer@sanfordhealth.org
• Study Contact Backup: Name: Katie Jensen; Phone Number: (605) 312-6983; Email: Katie.E.Jensen@SanfordHealth.org

Study Locations

• United States
  • North Dakota
    • Fargo, North Dakota, United States, 58122
      • Recruiting
      • Sanford Health
      • Contact: Katie Jensen; Phone Number: (605) 312-6983; Email: Katie.E.Jensen@SanfordHealth.org
      • Principal Investigator: Bruce Piatt, MD
      • Contact: Kathy Mcevoy; Phone Number: 701-417-6928; Email: kathryn.mcevoy@sanfordhealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Sanford Health
• Investigators: Principal Investigator: Bruce Piatt, MD, Sanford Health

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2018
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: February 19, 2019
• First Submitted That Met QC Criteria: February 26, 2019
• First Posted (Actual): February 28, 2019

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Wounds and Injuries; Leg Injuries; Pain, Postoperative; Knee Injuries; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Acetaminophen; Ibuprofen
• Other Study ID Numbers: SH Opioid Knee

Drug and device information, study documents

• 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