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Due to inability to demonstrate benefit in this patient population.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anakinra | Active Comparator | Two subcutaneous injections of anakinra (IL-1ra) were given, the first one hour prior to surgery and the second 24 hours after surgery. |
|
| Saline injection | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anakinra | Drug | An injection of 100 mg Anakinra was administered 1 hour prior to surgery and again 24 hours following surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 72 hours following surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 72 hours following surgery |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Robert L Lobato, MD | Stanford U | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Hospital and Clinics | Stanford | California | 94305 | United States |
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13 were enrolled and 3 participants withdrew prior to randomization
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| ID | Title | Description |
|---|---|---|
| FG000 | Anakinra | Two subcutaneous injections of anakinra (IL-1ra) were given, the first one hour prior to surgery and the second 24 hours after surgery. Anakinra: An injection of 100 mg Anakinra was administered 1 hour prior to surgery and again 24 hours following surgery. |
| FG001 | 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. Normal Saline: An injection of normal saline was administered 1 hour prior to surgery and again 24 hours following surgery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Anakinra | Two subcutaneous injections of anakinra (IL-1ra) were given, the first one hour prior to surgery and the second 24 hours after surgery. Anakinra: An injection of 100 mg Anakinra was administered 1 hour prior to surgery and again 24 hours following surgery. |
| BG001 | Saline Injection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | IL-1ra measurements were invalid due to cross-reaction with the assay platform. | Posted | Up to 72 hours following surgery |
|
Up to 72 hours following surgery plus 3 weeks follow-up
Adverse event collection was limited to incidence of wound infection, wound dehiscence, and venous thrombosis
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Anakinra | Two subcutaneous injections of anakinra (IL-1ra) were given, the first one hour prior to surgery and the second 24 hours after surgery. Anakinra: An injection of 100 mg Anakinra was administered 1 hour prior to surgery and again 24 hours following surgery. |
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The trial terminated early. We did not expect to see an effect in such a small number of subjects.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gary Peltz | Stanford University | 650-721-2487 | gpeltz@stanford.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D053590 | Interleukin 1 Receptor Antagonist Protein |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Normal Saline | Other | An injection of normal saline was administered 1 hour prior to surgery and again 24 hours following surgery. |
|
|
| 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) | Up to 72 hours following surgery |
| 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. | Up to 72 hours following surgery plus 3 weeks follow-up |
| 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. | Up to 72 hours following surgery plus 3 weeks follow-up |
| 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. | Up to 72 hours following surgery plus 3 weeks follow-up |
| Total Length of Hospital Stay | Total length of hospital stay for patients enrolled in the study. | Up to approximately 5 days maximum (admittance to discharge) |
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. Normal Saline: An injection of normal saline was administered 1 hour prior to surgery and again 24 hours following surgery. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 |
| 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. Normal Saline: An injection of normal saline was administered 1 hour prior to surgery and again 24 hours following surgery. |
|
| Secondary | 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 | Posted | Count of Participants | Participants | Up to 72 hours following surgery |
|
|
|
| Secondary | 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) | Participants with available data were analyzed. | Posted | Mean | Full Range | units on a Visual Analog scale | Up to 72 hours following surgery |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Up to 72 hours following surgery plus 3 weeks follow-up |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Up to 72 hours following surgery plus 3 weeks follow-up |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Up to 72 hours following surgery plus 3 weeks follow-up |
|
|
|
| Secondary | Total Length of Hospital Stay | Total length of hospital stay for patients enrolled in the study. | Posted | Median | Standard Deviation | hours | Up to approximately 5 days maximum (admittance to discharge) |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | 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. Normal Saline: An injection of normal saline was administered 1 hour prior to surgery and again 24 hours following surgery. | 0 | 5 | 0 | 5 | 0 | 5 |
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| D011506 | Proteins |
| D001685 | Biological Factors |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| PCA/IV - Morphine |
|
| PO - Oxycontin(tab) |
|
| PO - Percocet(tab) |
|
| PO - Acetaminophen(tab) |
|
| Pain Intensity on Stimulation Day One |
|
|
| Pain Intensity at Rest Day Two |
|
|
| Pain Intensity on Stimulation Day Two |
|
|