Back to resultsImmunomodulation, IL-1 Inhibition, and Postoperative Incisional Pain
Primary Purpose
Pain, Inflammation
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anakinra
Normal Saline
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring biomarkers
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:
- 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
- End-stage renal disease
- A history of diabetic neuropathy
- A malignancy other than basal cell carcinoma of the skin or in situ carcinoma of the cervix within the previous 5 years
- Leukopenia (white blood cell count < 2,000/ul)
- Thrombocytopenia (platelet count < 100,000/ul)
- Abnormal liver function test result (aspartate aminotransferase or alanine aminotransferase level ≥1.5-fold the upper limit of normal)
- A history or infection with tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus
- Pregnant or breastfeeding
Sites / Locations
- Stanford Hospital and Clinics
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Anakinra
Saline injection
Arm Description
Two subcutaneous injections of anakinra (IL-1ra) were given, the first one hour prior to surgery and the second 24 hours after surgery.
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.
Outcomes
Primary Outcome Measures
Concentration Levels of Inflammatory Mediators IL-1 Receptor Antagonist (IL-1ra) Present in Human Wounds Following Surgery With and Without the Use of Anakinra.
Tissue samples were 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 were analyzed for IL-1
Secondary Outcome Measures
Number of Participants With Analgesic Consumption During the 72 Hours Following Surgery
Analgesic consumption is reported as the count of participants receiving each analgesic type. Comparisons between the placebo and active drug groups were made at the conclusion of the study.
PCA/IV: Patient controlled Analgesia/ Intravenous
Post-operative Pain Intensity
Pain was measured on Day 1 and day 2 following surgery using a VAS scale at rest and on stimulation with Visual Analog Scale (VAS) of 1-10 (1=no pain and 10=worst pain)
Count of Participants Experiencing Wound Infection in the Study From Surgery Till the Time of Discharge From the Hospital
Evaluation of the surgical wound for symptoms of wound infection was made every day during hospitalization. Records from the first post-operative clinic visit were also evaluated for evidence of wound infection.
Count of Participants With Venous Thrombosis After Surgery During Hospitalization
Evaluation of the surgical wound for symptoms of venous thrombosis was made every day during hospitalization. Records from the first post-operative clinic visit were also evaluated for evidence of venous thrombosis.
Assess Rates of Wound Dehiscence
Evaluation of the surgical wound for symptoms of wound dehiscence was made every day during hospitalization. Records from the first post-operative clinic visit were also evaluated for evidence of wound dehiscence.
Total Length of Hospital Stay
Total length of hospital stay for patients enrolled in the study.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01466764
Brief Title
Immunomodulation, IL-1 Inhibition, and Postoperative Incisional Pain
Official Title
Immunomodulation, IL-1 Inhibition, and Postoperative Incisional Pain
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Terminated
Why Stopped
Due to inability to demonstrate benefit in this patient population.
Study Start Date
October 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Inflammation
Keywords
biomarkers
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anakinra
Arm Type
Active Comparator
Arm Description
Two subcutaneous injections of anakinra (IL-1ra) were given, the first one hour prior to surgery and the second 24 hours after surgery.
Arm Title
Saline injection
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Anakinra
Other Intervention Name(s)
Kineret
Intervention Description
An injection of 100 mg Anakinra was administered 1 hour prior to surgery and again 24 hours following surgery.
Intervention Type
Other
Intervention Name(s)
Normal Saline
Other Intervention Name(s)
No other name
Intervention Description
An injection of normal saline was administered 1 hour prior to surgery and again 24 hours following surgery.
Primary Outcome Measure Information:
Title
Concentration Levels of Inflammatory Mediators IL-1 Receptor Antagonist (IL-1ra) Present in Human Wounds Following Surgery With and Without the Use of Anakinra.
Description
Tissue samples were 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 were analyzed for IL-1
Time Frame
Up to 72 hours following surgery
Secondary Outcome Measure Information:
Title
Number of Participants With Analgesic Consumption During the 72 Hours Following Surgery
Description
Analgesic consumption is reported as the count of participants receiving each analgesic type. Comparisons between the placebo and active drug groups were made at the conclusion of the study.
PCA/IV: Patient controlled Analgesia/ Intravenous
Time Frame
Up to 72 hours following surgery
Title
Post-operative Pain Intensity
Description
Pain was measured on Day 1 and day 2 following surgery using a VAS scale at rest and on stimulation with Visual Analog Scale (VAS) of 1-10 (1=no pain and 10=worst pain)
Time Frame
Up to 72 hours following surgery
Title
Count of Participants Experiencing Wound Infection in the Study From Surgery Till the Time of Discharge From the Hospital
Description
Evaluation of the surgical wound for symptoms of wound infection was made every day during hospitalization. Records from the first post-operative clinic visit were also evaluated for evidence of wound infection.
Time Frame
Up to 72 hours following surgery plus 3 weeks follow-up
Title
Count of Participants With Venous Thrombosis After Surgery During Hospitalization
Description
Evaluation of the surgical wound for symptoms of venous thrombosis was made every day during hospitalization. Records from the first post-operative clinic visit were also evaluated for evidence of venous thrombosis.
Time Frame
Up to 72 hours following surgery plus 3 weeks follow-up
Title
Assess Rates of Wound Dehiscence
Description
Evaluation of the surgical wound for symptoms of wound dehiscence was made every day during hospitalization. Records from the first post-operative clinic visit were also evaluated for evidence of wound dehiscence.
Time Frame
Up to 72 hours following surgery plus 3 weeks follow-up
Title
Total Length of Hospital Stay
Description
Total length of hospital stay for patients enrolled in the study.
Time Frame
Up to approximately 5 days maximum (admittance to discharge)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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:
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
End-stage renal disease
A history of diabetic neuropathy
A malignancy other than basal cell carcinoma of the skin or in situ carcinoma of the cervix within the previous 5 years
Leukopenia (white blood cell count < 2,000/ul)
Thrombocytopenia (platelet count < 100,000/ul)
Abnormal liver function test result (aspartate aminotransferase or alanine aminotransferase level ≥1.5-fold the upper limit of normal)
A history or infection with tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus
Pregnant or breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert L Lobato, MD
Organizational Affiliation
Stanford U
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Hospital and Clinics
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Immunomodulation, IL-1 Inhibition, and Postoperative Incisional Pain
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