Bowel Care and Cardiovascular Function After Spinal Cord Injury

Study Overview
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Brief Summary
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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
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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.

Official Title
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Bowel Care and Cardiovascular Function After Spinal Cord Injury

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Drug: Lidocaine lubricant
* Other: Placebo lubricant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine lubricant (then placebo)<br>In this arm, on the first test day subjects will use lidocaine lubricant in their normal bowel care routine (rather than standard lubricating jelly). After a washout period they will repeat testing with the placebo lubricant. | Drug: Lidocaine lubricant<br>* Subjects using this intervention will receive 30 mL of Lidocaine hydrochloride jelly (2%)<br>* Other names: xylocaine jelly (2%) AstraZeneca;Other: Placebo lubricant<br>* Subjects using this intervention will receive 30 mL of placebo lubricant (no topical anesthetic)<br>* Other names: AMG MedPro lubricating Gel;|
| Placebo Comparator: Placebo lubricant (then lidocaine)<br>In this arm, on the first test day subjects will use regular lubricant (AMG MedPro lubricating gel) in their normal bowel care routine. After a washout period they will repeat testing with a the lidocaine lubricant. | Drug: Lidocaine lubricant<br>* Subjects using this intervention will receive 30 mL of Lidocaine hydrochloride jelly (2%)<br>* Other names: xylocaine jelly (2%) AstraZeneca;Other: Placebo lubricant<br>* Subjects using this intervention will receive 30 mL of placebo lubricant (no topical anesthetic)<br>* Other names: AMG MedPro lubricating Gel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure Change During Bowel Care | 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. | Measured continuously during bowel care (approximately one hour) on two occasions within 28 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Bowel Care Routine | The duration of bowel care routine will be recorded on two occasions within 28 days. | The exact duration of bowel care will be noted on two days within a 28 day period | 
| Cardiovascular Symptoms During Bowel Care | Cardiovascular symptoms will be recorded using a questionnaire on two occasions within 28 days. The questionnaire takes approximately 15 minutes to complete. The symptom score rated 13 measures (from 0-4) based on the frequency of symptoms experiences with a possible score ranging from 0-52. High scores denote more severe symtoms. | Measured by questionnaire (approximately 15 minutes) after bowel care on two occasions within 28 days. | 
| Heart Beat Abnormalities During Bowel Care (Number of Participants With Heart Beat Abnormalities) | 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. | Measured continuously during bowel care (approximately one hour) on two occasions within 28 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal cord injury, autonomic dysreflexia, blood pressure, bowel care management, defecation