Pulmonary Arterial Hypertension
Conditions
Keywords
Remodulin, Treprostinil
Brief summary
Treprostinil subcutaneous (under the skin) infusion is a very good medication for treating pulmonary arterial hypertension but infusion site pain may be very severe in some patients. The investigators plan to treat patients receiving treprostinil with a subcutaneous infusion of lidocaine (a local anesthestic) to treat the pain.
Interventions
DRUGLidocaine
Lidocaine
DRUGPlacebo
Placebo
Sponsors
Jewish General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* PAH * Treprostinil treatment for at least 3 months * Severe infusion site pain
Exclusion criteria
* Pregnancy/breastfeeding * Decompensated heart failure * Chronic liver disease * Abnormal electrolytes * Heart block (2/3 degree), sino-atrial block, idioventricular rhythm * Systolic systemic BP \<90mmHg * Bradycardia HR \<55 * Adverse reaction to lidocaine or other amide local anesthestic * Interacting medications (anti-arrhythmics, CYP1A2 inhibitors)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Questionnaire | 1 week | Short Form McGill Pain Questionnaire - Change from baseline over one week |
| Daily Pain Diary | 1 week | 10cm visual analogue scale (VAS) - Change in aggregated median/maximum scores over one week |
Secondary
| Measure | Time frame |
|---|---|
| proNT-BNP | 1 week |
| 6 minute walk | 1 week |
| Lidocaine level | 1 week |
Countries
Canada
Outcome results
None listed