Effects of Sustained-release Oral Sodium Nitrite on Postoperative Pain and Recovery Following Total Knee Arthroplasty

• Status: Not yet recruiting
• Trial end date: 2026-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will determine whether a drug called sodium nitrite helps improve pain and post-operative recovery associated with knee replacement surgery.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham

Criteria

Inclusion Criteria:

• Male and female individuals aged 18-70

• Ambulatory with knee pain for greater than 6 months prior to surgery, and willing and able to comply with all study requirements will be considered eligible.

Exclusion Criteria:

• Severe hypertension (systolic blood pressure greater than or equal to 200 mmHg or diastolic blood pressure greater than or equal to 120 mmHg);

• BMI greater than 45 kg/m2;

• Active smoker or stopped smoking within 6 months of enrollment;

• Active local or systemic malignancy, such as lung cancer or leukemia;

• Cardiovascular disease resulting in dyspnea at rest;

• Peripheral neurovascular disease;

• Anemia;

• Hematological disease (eg, coagulopathy, sickle cell disease/anemia);

• Hemoglobin variant;

• Glucose-6-phosphate dehydrogenase deficiency;

• Methemoglobin reductase deficiency;

• Known sensitivity to nitrites;

• Liver disease;

• Use of phosphodiesterase type 5 inhibitors;

• Use of sildenafil (Viagra);

• Systemic treatment with antibiotics, immunosuppressants including corticosteroids, medications for migraine, allopurinol, tricyclic antidepressants, antihistamines, and/or nitrates currently or in the last month;

• Use of nitrovasodilators (e.g. GTN) within the last month;

• Use of protein pump inhibitors within the last month;

• History of substance abuse;

• Recent surgery or hospitalization (within last 6 months);

• Inability to swallow a pill;

• Failure to provide full consent;

• Involvement with a worker's compensation, personal injury, or other legal matter related to participant health.