Clinical trial NCT01567605: Bowel Care and Cardiovascular Function After Spinal Cord Injury
Official title: Bowel Care and Cardiovascular Function After Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Spinal Cord Injury
Keywords: spinal cord injury
autonomic dysreflexia
blood pressure
bowel care management
defecation
Lead sponsor: Simon Fraser University
Sponsor class: OTHER
Collaborators: name: University of British Columbia
First posted: 2012-03-30
Enrollment: 13
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The main goal of this project is to determine the effects of lidocaine lubricant on cardiovascular function during routine bowel care in individuals with spinal cord injury. Bowel care is a common trigger of blood pressure and heart rate changes after spinal cord injury. In this project, we will be measuring blood pressure and heart rate non-invasively during normal bowel routine (which can be performed in the subject's home or at one of the investigators facilities). The measurements will occur twice over a period of 28 days: once using lidocaine lubricant and once using normal (placebo) lubricant. The recording equipment will be attached and subjects will have complete privacy during their bowel routine. The trial will be double-blind, meaning that neither the subject or the Nurse Continence Advisor who assists with testing will know which lubricant is being used for each test.

The use of a lubricant gel containing an anesthetic is the standard of care in many hospital facilities when performing bowel care for individuals with spinal cord injury; however, it is not often used in the home setting. It is thought that using anaesthetic might reduce the cardiovascular effects of bowel care after spinal cord injury. However, it is not known whether this is the case.

The investigators hypothesize that the lidocaine lubricant will alleviate some of the blood pressure and heart rate changes that occur during bowel care.

Detailed description: The primary purpose of this study is to investigate the effects of topical anesthesia on cardiovascular changes triggered by bowel care in people with spinal cord injury.

In people with spinal cord injury, episodes of high blood pressure are common during strong sensory stimuli such as those present during routine bowel care. These episodes of high blood pressure can be dangerous due to the magnitude of blood pressure increase and because they can be accompanied by irregular heart beats. This condition, known as autonomic dysreflexia, is most common in individuals with high-level injuries.

The experience of autonomic dysreflexia can vary widely between individuals: some have goosebumps, sweating, facial flushing or headaches, while others have no symptoms at all, despite their changes in heart rate and blood pressure.

The use of a lubricant gel containing an anesthetic, lidocaine lubricant, is the standard of care in many hospital facilities when performing bowel care for individuals with spinal cord injury; however, it is not often used in the home setting. It is thought that using anaesthetic might reduce the cardiovascular effects of bowel care after spinal cord injury. However, it is not known whether this is the case. We do not yet know the long-term consequences of these short-term elevations in blood pressure during autonomic dysreflexia, but given that they are often associated with discomfort, and have been known to be associated with more severe events such as stroke, it would be beneficial to reduce their occurrence.

Therefore, we will test whether lidocaine lubricant compared to a placebo lubricant improves the symptoms and signs of autonomic dysreflexia during bowel care in people with spinal cord injury.

Eligibility criteria: Inclusion Criteria:

* traumatic spinal cord injury at least one year ago
* regular bowel care routine (at least four weeks)

Exclusion Criteria:

* cauda equina or conus lesion
* currently use ventilator
* colostomy, or do not perform regular bowel care for any reason
* any skin breakdown (pressure sores)
* do not speak English
* are under 19 years old
* are pregnant or think you might be pregnant
* medical/psychiatric condition or substance abuse that is likely to affect your ability to complete this study
* currently using medications containing lidocaine
* allergy to lidocaine

Primary outcomes:
measure: Blood Pressure Change During Bowel Care
timeFrame: Measured continuously during bowel care (approximately one hour) on two occasions within 28 days.
Secondary outcomes:
measure: Duration of Bowel Care Routine
timeFrame: The exact duration of bowel care will be noted on two days within a 28 day period
measure: Cardiovascular Symptoms During Bowel Care
timeFrame: Measured by questionnaire (approximately 15 minutes) after bowel care on two occasions within 28 days.
measure: Heart Beat Abnormalities During Bowel Care (Number of Participants With Heart Beat Abnormalities)
timeFrame: Measured continuously during bowel care (approximately one hour) on two occasions within 28 days.
Other outcomes:
Locations:
city: Burnaby
country: Canada
facility: Simon Fraser University
state: British Columbia
city: Vancouver
country: Canada
facility: International Collaboration on Repair Discoveries
state: British Columbia
Study officials:
affiliation: Simon Fraser University and International Collaboration on Repair Discoveries (ICORD)
name: Victoria E Claydon, PhD
role: PRINCIPAL_INVESTIGATOR
References: