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Immunomodulation, IL-1 Inhibition, and Postoperative Incisional Pain

This study is currently recruiting participants.
Verified November 2011 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Robert L Lobato, MD, MS, Stanford University
ClinicalTrials.gov Identifier:
NCT01466764
First received: November 1, 2011
Last updated: November 7, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention
Pain
Inflammation
 Drug: Anakinra
Drug: Normal Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Immunomodulation, IL-1 Inhibition, and Postoperative Incisional Pain

Resource links provided by NLM:

Drug Information available for: Anakinra
U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Concentration levels of inflammatory mediators (IL-1, IL-6, IL-8 and TNF-a) present in human wounds following surgery with and without the use of anakinra. [ Time Frame: 72 hours following surgery ] [ Designated as safety issue: No ]
    Tissue samples will be collected at the surgical wound site at 3 time points during the 1st 72 hours following surgery. Tissue samples from subjects receiving placebo, and subjects receiving anakinra injections pre, and post op will be analyzed for IL-1, IL-6, IL-8 and TNF-a.


Secondary Outcome Measures:
  • Quantify the total analgesic requirement during the 72 hours following surgery [ Time Frame: 72 hours following surgery ] [ Designated as safety issue: No ]
    All analgesic consumption will be recorded. Comparisons between the placebo and active drug groups will be made at the conclusion of the study.

  • Post-operative pain response will be measured [ Time Frame: 72 hours following surgery ] [ Designated as safety issue: No ]

    Pain will be measured at various time points in the 1st 72 hours following surgery by:

    1. Using a VAS scale at rest and with activity
    2. Mapping the area of hyperalgesia surrounding the surgical wound will using vonFrey's fibers

  • Assess rates of wound infection [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
    Evaluation of the surgical wound for symptoms of wound infection will be made every day during hospitalization. Records from the first post-operative clinic visit will also be evaluated for evidence of wound infection.

  • Assess rates of venous thrombosis [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
    Evaluation of the surgical wound for symptoms of venous thrombosis will be made every day during hospitalization. Records from the first post-operative clinic visit will also be evaluated for evidence of venous thrombosis.

  • Assess rates of wound dehiscence [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
    Evaluation of the surgical wound for symptoms of wound dehiscence will be made every day during hospitalization. Records from the first post-operative clinic visit will also be evaluated for evidence of wound dehiscence.

  • Total length of hospital stay [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    We will record total length of hospital stay for patients enrolled in the study.


Estimated Enrollment: 50
Study Start Date: October 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Anakinra Drug: Anakinra
An injection of Anakinra will be administered 1 hour prior to surgery and again 24 hours following surgery.
Other Name: Kineret
Placebo Comparator: Saline injection Drug: Normal Saline
An injection of normal saline will be administered 1 hour prior to surgery and again 24 hours following surgery.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01466764

Contacts
Contact: Priya Hegde, MS 650-724-2742 priyavhegde@gmail.com

Locations
United States, California
Stanford Hospital and Clinics Recruiting
Stanford, California, United States, 94305
Contact: Priya V Hegde, MS     650-724-2742     priyavhegde@gmail.com    
Principal Investigator: Robert L Lobato, MD            
Sponsors and Collaborators
Robert L Lobato, MD, MS
Investigators
Principal Investigator: Robert L Lobato, MD Stanford U
  More Information

No publications provided

Responsible Party: Robert L Lobato, MD, MS, MD, Instructor, Primary Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT01466764     History of Changes
Other Study ID Numbers: SU-10312011-8587
Study First Received: November 1, 2011
Last Updated: November 7, 2011
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Stanford University:
biomarkers

Additional relevant MeSH terms:
Inflammation
Pathologic Processes
Interleukin 1 Receptor Antagonist Protein
 Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013