Immunomodulation, IL-1 Inhibition, and Postoperative Incisional Pain

• Status: Terminated
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators hypothesize that perioperative administration of anakinra will reduce incisional pain by lowering the concentration of inflammatory mediators in surgical wounds. This knowledge is important because it suggests a new, previously unexplored pharmacological target for the control of postoperative incisional pain.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Robert L Lobato, MD, MS; Stanford University
• Treatments: Interleukin 1 Receptor Antagonist Protein

Criteria

Inclusion Criteria:

-Patients 18 years of age and older presenting to the Stanford Preoperative Evaluation Clinic prior to elective orthopedic surgical procedures or elective vascular surgical procedures not involving the abdominal aorta or carotid arteries.

Exclusion Criteria:

Patients will be excluded from participation if they have one or more of the following conditions:

1. Evidence of active local or systemic infection as demonstrated by fever, leukocytosis (white blood cell count > 11,000/ul), productive cough, new infiltrate on chest x-ray, or purulent drainage from any source

2. End-stage renal disease

3. A history of diabetic neuropathy

4. A malignancy other than basal cell carcinoma of the skin or in situ carcinoma of the cervix within the previous 5 years

5. Leukopenia (white blood cell count < 2,000/ul)

6. Thrombocytopenia (platelet count < 100,000/ul)

7. Abnormal liver function test result (aspartate aminotransferase or alanine aminotransferase level ≥1.5-fold the upper limit of normal)

8. A history or infection with tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus

9. Pregnant or breastfeeding