Evaluation of Propranolol's Effect on Pain and Inflammation.
Information source: Stanford University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain Measurement
Intervention: Propranolol (Drug); Alfentanil (Drug); Placebo (Drug)
Sponsored by: Martin Angst
Official(s) and/or principal investigator(s):
Martin S Angst, Principal Investigator, Affiliation: Stanford University
Previous studies have shown that the beta-adrenergic system plays a role in processing pain
and the expression of hyperalgesia. Recent studies have investigated the analgesic effects,
and potential anti-hyperalgesic effects (using a model of opioid induced (OIH) hyperalgesia)
of propranolol, a beta adrenergic antagonist. We plan to further investigate the analgesic
effects, and the potential anti inflammatory effects, of propranolol and compare those
effects to alfentanil, an opioid of known effect, and placebo
Official title: Investigation of Analgesic and Anti-inflammatory Effects of Beta-adrenergic Antagonist Propranolol
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Basic Science
Quantitative sensory pain measurements
Proteomic analysis of local tissue samples, IL6 as a lead compound
Secondary outcome: Quantified skin inflammation (median flux)
This study is a double blind-placebo controlled study in which subjects will be exposed to
propranolol infusion during one study day, the opioid alfentanil on another day, and placebo
infusion during a third study day. The infusion order will be randomized, and the
participant and individual conducting the pain testing will both be blinded to the
Propranolol, alfentanil, and placebo infusions will be administered intravenously using a
computer-controlled infusion pump that can be set to accurately administer a target plasma
concentration of drug.
On one study day subjects will receive propranolol at a target concentration of 30ng/ml over
3 hours time. On another study day subjects will receive 100ng/ml alfentanil over 3 hours,
and on a third study day subjects will receive placebo (normal saline) using a
computer-controlled infusion paradigm.
Sites to be evaluated for response to propranolol and placebo will be established in 2 ways.
One will use ultraviolet B (UVB) exposure to create a "sunburn" causing inflammation and
pain. The other will be a model of acute injury using an array of micro-needles.
Means of evaluation of injured, and non-injured sites will be pain testing, interstitial
fluid sampling for detection of pro-inflammatory, and pro-nociceptive cytokines, and laser
doppler evaluation of tissue perfusion.
Subjects will be recruited using fliers. Interested participants will contact the study
team, their questions will be answered, and an appointment for screening will be made.
Minimum age: N/A.
Maximum age: N/A.
Inclusion Criteria: 1) Age 18-65 2) Skin type II-IV according to classification of
Fitzpatrick 3) Willing and able to sign an informed consent form and Health Insurance
Portability and Accountability Act (HIPAA) authorization and to comply with study
Exclusion Criteria: 1) History of acute or chronic illness that contraindicate the use of
propranolol, may hinder study procedures, or confuse interpretation of the data (e. g.
cardiac, dermatological, neurological, psychiatric or addictive diseases) 2) Clinically
significant cardiovascular, pulmonary, hepatic or renal diseases 3) Pregnant or
breast-feeding 4) Intake of prescription drugs with anti/pro-inflammatory action 5) Intake
of prescription drugs with anti/pro-analgesic action 6) Inability to abstain from any
anti/pro-inflammatory, or analgesic drugs 48 hours before, or during the study session 7)
Inability to obtain at least 6 hours of sleep during the night preceding the study session
8) Known sensitivity or allergy to propranolol or alfentanil 9) Any history of drug or
Locations and Contacts
Stanford University School of Medicine, Stanford, California 94305, United States
Starting date: January 2010
Last updated: June 18, 2013