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Lidocaine Subcutaneous Infusion for Control of Treprostinil Related Site Pain

This study has been terminated.
(Safety considerations)
Information provided by (Responsible Party):
Dr David Langleben, Jewish General Hospital Identifier:
First received: September 9, 2011
Last updated: April 4, 2012
Last verified: April 2012
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.

Condition Intervention Phase
Pulmonary Arterial Hypertension Drug: Lidocaine Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lidocaine Subcutaneous Infusion for Control of Treprostinil Related Site Pain

Resource links provided by NLM:

Further study details as provided by Dr David Langleben, Jewish General Hospital:

Primary Outcome Measures:
  • Pain Questionnaire [ Time Frame: 1 week ]
    Short Form McGill Pain Questionnaire - Change from baseline over one week

  • Daily Pain Diary [ Time Frame: 1 week ]
    10cm visual analogue scale (VAS) - Change in aggregated median/maximum scores over one week

Secondary Outcome Measures:
  • proNT-BNP [ Time Frame: 1 week ]
  • 6 minute walk [ Time Frame: 1 week ]
  • Lidocaine level [ Time Frame: 1 week ]

Enrollment: 4
Study Start Date: January 2012
Study Completion Date: April 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lidocaine Drug: Lidocaine
Placebo Comparator: Placebo
Remodulin only
Drug: Placebo


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT01433328

Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
Jewish General Hospital
Principal Investigator: David Langleben, MD Chair, Cardiology Department
  More Information

Responsible Party: Dr David Langleben, Chair, Cardiology Department, Jewish General Hospital Identifier: NCT01433328     History of Changes
Other Study ID Numbers: JGH-11-096
Study First Received: September 9, 2011
Last Updated: April 4, 2012

Keywords provided by Dr David Langleben, Jewish General Hospital:

Additional relevant MeSH terms:
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents processed this record on September 21, 2017