Comparing opioids and non-opioids for pain management after knee surgery

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

This study is testing whether non-opioid pain medications can work as well as opioids for people recovering from knee surgery.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 148 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Sanford Health (Academic / other)
• Locations: 1 site (Fargo, North Dakota)
• Trial ID: NCT03858231 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of opioid versus non-opioid medications for pain relief following knee arthroscopic surgery. It aims to determine if commonly used non-narcotic medications can provide comparable pain relief to narcotic medications. Additionally, the study will assess how patient characteristics, such as gender and pre-operative symptoms, influence pain levels and medication usage post-surgery.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 undergoing elective arthroscopic knee surgery.

Not a fit: Patients with a history of chronic opioid use, substance abuse, or those undergoing knee ligament reconstructions will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to safer pain management strategies that reduce reliance on opioids after knee surgery.

How similar studies have performed: Other studies have shown promising results in comparing opioid and non-opioid pain management strategies, indicating this approach is relevant and potentially beneficial.

Eligibility 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. 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

Where this trial is running

Fargo, North Dakota

• Sanford Health — Fargo, North Dakota, United States (Recruiting)

Study contacts

• Principal investigator: Bruce Piatt, MD — Sanford Health
• Study coordinator: Amy Tuchscherer

Conditions Knee Injuries; Pain, Postoperative; Opioid Use