Bowel Care and Cardiovascular Function After Spinal Cord Injury
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|ClinicalTrials.gov Identifier: NCT01567605|
Recruitment Status : Completed
First Posted : March 30, 2012
Last Update Posted : April 16, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury||Drug: Lidocaine lubricant Other: Placebo lubricant||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Bowel Care and Cardiovascular Function After Spinal Cord Injury|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||December 2018|
|Actual Study Completion Date :||December 2018|
Experimental: Lidocaine lubricant
In this arm, subjects will use lidocaine lubricant in their normal bowel care routine (rather than standard lubricating jelly).
Drug: Lidocaine lubricant
Subjects using this intervention will receive 30 mL of Lidocaine hydrochloride jelly (2%)
Other Name: xylocaine jelly (2%) AstraZeneca
Placebo Comparator: Placebo lubricant
In this arm, subjects will use regular lubricant (AMG MedPro lubricating gel) in their normal bowel care routine.
Other: Placebo lubricant
Subjects using this intervention will receive 30 mL of placebo lubricant (no topical anesthetic)
Other Name: AMG MedPro lubricating Gel
- Blood pressure change during bowel care [ Time Frame: Measured continuously during bowel care (approximately one hour) on two occasions within 28 days. ]Beat-to-beat blood pressure will be recorded using a finger blood pressure cuff (Finometer) on two occasions within 28 days, for up to one hour on each occasion.
- Duration of bowel care routine [ Time Frame: The exact duration of bowel care will be noted on two days within a 28 day period ]The duration of bowel care routine will be recorded on two occasions within 28 days.
- Cardiovascular symptoms during bowel care [ Time Frame: Measured by questionnaire (approximately 15 minutes) after bowel care on two occasions within 28 days. ]Cardiovascular symptoms will be recorded using a questionnaire on two occasions within 28 days. The questionnaire takes approximately 15 minutes to complete.
- Heart beat abnormalities during bowel care [ Time Frame: Measured continuously during bowel care (approximately one hour) on two occasions within 28 days. ]3-lead electrocardiogram will be recorded throughout the duration of bowel care on two occasions within 28 days, for up to one hour on each occasion.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01567605
|Canada, British Columbia|
|Simon Fraser University|
|Burnaby, British Columbia, Canada, V5A 1S6|
|International Collaboration on Repair Discoveries|
|Vancouver, British Columbia, Canada, V5Z1M9|
|Principal Investigator:||Victoria E Claydon, PhD||Simon Fraser University and International Collaboration on Repair Discoveries (ICORD)|