Clinical trial NCT01466764: Immunomodulation, IL-1 Inhibition, and Postoperative Incisional Pain
Official title: Immunomodulation, IL-1 Inhibition, and Postoperative Incisional Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain
Inflammation
Keywords: biomarkers
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2011-11-08
Enrollment: 13
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: 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.

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. The investigators will administer two doses of Anakinra via an injection under the skin, one dose one hour before surgery and a second dose on the first postoperative day (24 hours after surgery). The investigators will remove fluid from the surgical incisions using a small plastic catheter placed under skin during surgery and measure the amounts of pain- causing inflammatory mediators. The investigators will also measure the amount of pain the participant is experiencing using questions about pain intensity and by gently touching the incision to determine sensitivity of the incision site.

Eligibility 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

Primary outcomes:
measure: Concentration Levels of Inflammatory Mediators IL-1 Receptor Antagonist (IL-1ra) Present in Human Wounds Following Surgery With and Without the Use of Anakinra.
timeFrame: Up to 72 hours following surgery
Secondary outcomes:
measure: Number of Participants With Analgesic Consumption During the 72 Hours Following Surgery
timeFrame: Up to 72 hours following surgery
measure: Post-operative Pain Intensity
timeFrame: Up to 72 hours following surgery
measure: Count of Participants Experiencing Wound Infection in the Study From Surgery Till the Time of Discharge From the Hospital
timeFrame: Up to 72 hours following surgery plus 3 weeks follow-up
measure: Count of Participants With Venous Thrombosis After Surgery During Hospitalization
timeFrame: Up to 72 hours following surgery plus 3 weeks follow-up
measure: Assess Rates of Wound Dehiscence
timeFrame: Up to 72 hours following surgery plus 3 weeks follow-up
measure: Total Length of Hospital Stay
timeFrame: Up to approximately 5 days maximum (admittance to discharge)
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Hospital and Clinics
state: California
Study officials:
affiliation: Stanford U
name: Robert L Lobato, MD
role: PRINCIPAL_INVESTIGATOR
References: