Immunomodulation, IL-1 Inhibition, and Postoperative Incisional Pain

Pain Clinical Trial

Official title: Immunomodulation, IL-1 Inhibition, and Postoperative Incisional Pain

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inflammation
• Pain

• NCT number: NCT01466764
• Study type: Interventional
• Source: Stanford University
• Contact: Priya Hegde, MS
• Phone: 650-724-2742
• Email: priyavhegde@gmail.com
• Status: Recruiting
• Phase: N/A
• Start date: October 2011
• Completion date: August 2012