Clinical trial NCT05893160: Effects of Sustained-release Oral Sodium Nitrite on Postoperative Pain and Recovery Following Total Knee Arthroplasty
Official title: Effects of Sustained-release Oral Sodium Nitrite Supplementation on Pain-related Outcomes and Peri- and Postoperative Physiology in People Undergoing Unilateral All-component Revision Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Pain
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2023-06-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: The goal of this study is to examine the potential for oral sodium nitrite supplementation to reduce postoperative pain and inflammation and improve functional recovery in individuals undergoing unilateral revision total knee replacement. A sustained release formulation of sodium nitrite (40 mg) administered twice daily will be compared with placebo for a 30-day treatment period. Primary objectives are to evaluate pain and markers of functional improvement.

Eligibility 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.

Primary outcomes:
measure: Opioid Requirements
timeFrame: 30 days
measure: Short-form McGill Pain Questionnaire (SF-MPQ)
timeFrame: 30 days
measure: Brief Pain Inventory (BPI) short form
timeFrame: 30 days
measure: Pain ratings
timeFrame: 30 days
measure: Quality of Recovery (QoR-15) questionnaire
timeFrame: 30 days
measure: Physical function
timeFrame: 30 days
measure: Leg girth measurement
timeFrame: 30 days
measure: White blood cell count
timeFrame: 30 days
measure: Immune cell markers
timeFrame: 30 days
measure: Blood markers v1
timeFrame: 30 days
measure: Blood markers v2
timeFrame: 30 days
measure: Timed-Up-and-Go test
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Alabama at Birmingham
name: Jennifer DeBerry, PhD
role: PRINCIPAL_INVESTIGATOR
References: