Status:
TERMINATED
Immunomodulation, IL-1 Inhibition, and Postoperative Incisional Pain
Lead Sponsor:
Stanford University
Conditions:
Pain
Inflammation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 im...
Detailed Description
This study will test whether administration of anakinra, an IL-1 receptor antagonist, will decrease pain and improve wound healing in patients undergoing vascular or orthopedic surgical procedures. Th...
Eligibility Criteria
Inclusion
- 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
- Patients will be excluded from participation if they have one or more of the following conditions:
- 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
- End-stage renal disease
- A history of diabetic neuropathy
- A malignancy other than basal cell carcinoma of the skin or in situ carcinoma of the cervix within the previous 5 years
- Leukopenia (white blood cell count \< 2,000/ul)
- Thrombocytopenia (platelet count \< 100,000/ul)
- Abnormal liver function test result (aspartate aminotransferase or alanine aminotransferase level ≥1.5-fold the upper limit of normal)
- A history or infection with tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus
- Pregnant or breastfeeding
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01466764
Start Date
October 1 2011
End Date
June 1 2013
Last Update
August 9 2017
Active Locations (1)
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1
Stanford Hospital and Clinics
Stanford, California, United States, 94305