Lidocaine Subcutaneous Infusion for Control of Treprostinil Related Site Pain
- Registration Number
- NCT01433328
- Lead Sponsor
- Jewish General Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 4
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Placebo Remodulin only Lidocaine Lidocaine -
- Primary Outcome Measures
Name Time Method Daily Pain Diary 1 week 10cm visual analogue scale (VAS) - Change in aggregated median/maximum scores over one week
Pain Questionnaire 1 week Short Form McGill Pain Questionnaire - Change from baseline over one week
- Secondary Outcome Measures
Name Time Method 6 minute walk 1 week Lidocaine level 1 week proNT-BNP 1 week
Trial Locations
- Locations (1)
Jewish General Hospital
🇨🇦Montreal, Quebec, Canada