Immunomodulation, IL-1 Inhibition, and Postoperative Incisional Pain

Pain Clinical Trial

Official title:

Immunomodulation, IL-1 Inhibition, and Postoperative Incisional Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01466764
• Other study ID #: SU-10312011-8587
• Status: Recruiting
• Phase: N/A
• First received: November 1, 2011
• Last updated: November 7, 2011
• Start date: October 2011
• Est. completion date: August 2012

Study information

• Verified date: November 2011
• Source: Stanford University
• Contact: Priya Hegde, MS
• Phone: 650-724-2742
• Email: priyavhegde[@]gmail.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Intervention

Drug:
• Anakinra
An injection of Anakinra will be administered 1 hour prior to surgery and again 24 hours following surgery.
• Normal Saline
An injection of normal saline will be administered 1 hour prior to surgery and again 24 hours following surgery.

Locations

Country	Name	City	State
United States	Stanford Hospital and Clinics	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Robert L Lobato, MD, MS

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	72 hours following surgery	No
Secondary	Quantify the total analgesic requirement during the 72 hours following surgery	All analgesic consumption will be recorded. Comparisons between the placebo and active drug groups will be made at the conclusion of the study.	72 hours following surgery	No
Secondary	Post-operative pain response will be measured	Pain will be measured at various time points in the 1st 72 hours following surgery by: Using a VAS scale at rest and with activity; Mapping the area of hyperalgesia surrounding the surgical wound will using vonFrey's fibers	72 hours following surgery	No
Secondary	Assess rates of wound infection	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.	3 weeks	Yes
Secondary	Assess rates of venous thrombosis	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.	3 weeks	Yes
Secondary	Assess rates of wound dehiscence	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.	3 weeks	Yes
Secondary	Total length of hospital stay	We will record total length of hospital stay for patients enrolled in the study.	3 weeks	No