N/A
Completed N=10
Evaluation of Propranolol's Effect on Pain and Inflammation.
Pain Measurement
Source: ClinicalTrials.gov NCT01094574 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcomePrimary: Change From Baseline in Heat Pain Threshold During Infusion in Non-Inflamed Skin — 1.01; 0.14; 0.01 degree centigrade
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Heat Pain Threshold During Infusion in Non-Inflamed Skin |
1.01; 0.14; 0.01 | — |
| PRIMARY Change From Baseline in Heat Pain Threshold During Infusion in Inflamed Skin |
3.77; 0.09; -0.28 | — |
| PRIMARY Change From Baseline in Mechanical Pain Threshold During Infusion in Non-Inflamed Skin |
10.16; -11.22; -9.53 | — |
| PRIMARY Change From Baseline in Mechanical Pain Threshold During Infusion in Inflamed Skin |
29.18; -9.07; -11.00 | — |
| SECONDARY TNFα (ng/mL) Change From Baseline During Infusion |
4.92; 5.78; 2.93 | — |
| SECONDARY IL-1β (ng/mL) Change From Baseline During Infusion |
5.39; 6.99; 7.53 | — |
| SECONDARY IL-2 (ng/mL) Change From Baseline During Infusion |
2.38; 3.08; 1.65 | — |
| SECONDARY IL-6 (ng/mL) Change From Baseline During Infusion |
344.2; 214.0; 153.6 | — |
| SECONDARY GMCSF (ng/mL) Change From Baseline During Infusion |
7.85; 10.75; 6.48 | — |
| SECONDARY IL-8 (ng/mL) Change From Baseline During Infusion |
486.3; 621.5; 398.7 | — |
| SECONDARY IL-10 (ng/mL) Change From Baseline During Infusion |
0.35; 0.84; -0.01 | — |
| SECONDARY IL-12 (ng/mL) Change From Baseline During Infusion |
2.12; 3.41; 3.38 | — |
| SECONDARY Change in Arbitrary Perfusion Units From Baseline During Drug Infusion |
-234; -217; -178 | — |
Eligibility Criteria
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 procedures
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 alcohol abuse
Data sourced from ClinicalTrials.gov (NCT01094574). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.