Lidocaine Subcutaneous Infusion for Control of Treprostinil Related Site Pain

• Sponsor: Jewish General Hospital (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01433328
• Collaborator: (none)
• Enrollment: 4
• Location: 1
• Arms: 2
• Duration (Months): 3
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Arterial Hypertension	Drug: Lidocaine; Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 4 participants
• 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
• Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: Apr 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lidocaine	Drug: Lidocaine; Lidocaine
Placebo Comparator: Placebo Remodulin only	Drug: Placebo; Placebo

Outcome Measures

Primary Outcome Measures

1. Pain Questionnaire [1 week]

   Short Form McGill Pain Questionnaire - Change from baseline over one week

2. Daily Pain Diary [1 week]

   10cm visual analogue scale (VAS) - Change in aggregated median/maximum scores over one week

Secondary Outcome Measures

1. proNT-BNP [1 week]

2. 6 minute walk [1 week]

3. Lidocaine level [1 week]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• 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

Locations

	Site	City	State	Country	Postal Code
1	Jewish General Hospital	Montreal	Quebec	Canada	H3T 1E2

Sponsors and Collaborators

• Jewish General Hospital

Investigators

• Principal Investigator: David Langleben, MD, Chair, Cardiology Department

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr David Langleben, Chair, Cardiology Department, Jewish General Hospital
• ClinicalTrials.gov Identifier: NCT01433328
• Other Study ID Numbers: JGH-11-096
• First Posted: Sep 13, 2011
• Last Update Posted: Mar 3, 2020
• Last Verified: Feb 1, 2020

• Keywords provided by Dr David Langleben, Chair, Cardiology Department, Jewish General Hospital: Remodulin; Treprostinil
• Additional relevant MeSH terms: Pulmonary Arterial Hypertension; Hypertension; Lidocaine

Study Results

No Results Posted as of Mar 3, 2020