Immunomodulation, IL-1 Inhibition, and Postoperative Incisional Pain

NCT ID: NCT01466764

Last Updated: 2017-08-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2013-06-30

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.

Conditions

Pain; Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Anakinra

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

Group Type: ACTIVE_COMPARATOR

Anakinra

Intervention Type: DRUG

An injection of 100 mg Anakinra was administered 1 hour prior to surgery and again 24 hours following surgery.

Saline injection

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.

Group Type: PLACEBO_COMPARATOR

Normal Saline

Intervention Type: OTHER

An injection of normal saline was administered 1 hour prior to surgery and again 24 hours following surgery.

Interventions

Anakinra

An injection of 100 mg Anakinra was administered 1 hour prior to surgery and again 24 hours following surgery.

Intervention Type: DRUG

Normal Saline

An injection of normal saline was administered 1 hour prior to surgery and again 24 hours following surgery.

Intervention Type: OTHER

Other Intervention Names

Kineret; No other name

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Gary Peltz

Professor of Anesthesiology, Perioperative and Pain Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert L Lobato, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford U

Locations

Stanford Hospital and Clinics

Stanford, California, United States

Countries

United States

Other Identifiers

SU-10312011-8587

Identifier Type: -

Identifier Source: org_study_id