Immunomodulation, IL-1 Inhibition, and Postoperative Incisional Pain

Stanford University

Status: Terminated

Conditions: Inflammation; Pain

Treatments: Drug: Anakinra; Other: Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01466764

SU-10312011-8587

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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13 participants in 2 patient groups, including a placebo group

Anakinra

Active Comparator group

Description:

Two subcutaneous injections of anakinra (IL-1ra) were given, the first one hour prior to surgery and the second 24 hours after surgery.

Treatment:

Drug: Anakinra

Saline injection

Placebo Comparator group

Description:

Two subcutaneous injections of normal saline (same volume as the anakinra group injection) were given, the first one hour prior to surgery and the second 24 hours after surgery.

Treatment:

Other: Normal Saline