Immunomodulation, IL-1 Inhibition, and Postoperative Incisional Pain

NCT01466764 | Terminated Results DMC

• 1 other identifier: SU-10312011-8587
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Inflammation

Keywords

biomarkers

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Number of Participants With Analgesic Consumption During the 72 Hours Following Surgery

  Up to 72 hours following surgery

• Post-operative Pain Intensity

  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

  Up to 72 hours following surgery plus 3 weeks follow-up

• Count of Participants With Venous Thrombosis After Surgery During Hospitalization

  Up to 72 hours following surgery plus 3 weeks follow-up

• Assess Rates of Wound Dehiscence

  Up to 72 hours following surgery plus 3 weeks follow-up

Study Arms (2)

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.

Drug: Anakinra

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.

Other: Normal Saline

Interventions

Anakinra DRUG

An injection of 100 mg Anakinra was administered 1 hour prior to surgery and again 24 hours following surgery.

Also known as: Kineret

Anakinra

Normal Saline OTHER

An injection of normal saline was administered 1 hour prior to surgery and again 24 hours following surgery.

Also known as: No other name

Saline injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Hospital and Clinics

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Pain; Inflammation

Interventions

Interleukin 1 Receptor Antagonist Protein; Saline Solution

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

The trial terminated early. We did not expect to see an effect in such a small number of subjects.

Results Point of Contact

• Title: Gary Peltz
• Organization: Stanford University

gpeltz@stanford.edu

650-721-2487

Study Officials

• Robert L Lobato, MD

  Stanford U

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology, Perioperative and Pain Medicine

Study Record Dates

• First Submitted: November 1, 2011
• First Posted: November 8, 2011
• Study Start: October 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: June 1, 2013
• Last Updated: August 9, 2017
• Results First Posted: July 6, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)