Bowel Care and Cardiovascular Function After Spinal Cord Injury (NCT01567605) | Clinical Trial Compass
CompletedPhase 4
Bowel Care and Cardiovascular Function After Spinal Cord Injury
Canada13 participantsStarted 2012-03
Plain-language 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.
Who can participate
Age range
19 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial looked at blood pressure changes during bowel care in people with spinal cord injury — is blood pressure instability during bowel routines something I should be concerned about given my level of injury?
2Since this was a Phase 4 trial that has already been completed, has my doctor seen or reviewed any of the published results, and what do the findings suggest about safer bowel care practices for someone in my situation?
3Autonomic dysreflexia can cause dangerous spikes in blood pressure during bowel care — is this a risk for me specifically, and should we be monitoring my blood pressure during my bowel routine at home?
4Are there particular bowel care methods or techniques that this kind of research suggests may be less likely to cause cardiovascular stress, and would any of them be appropriate for my care plan?
5Given that this trial is now completed, are there follow-up studies or updated clinical guidelines on bowel management after spinal cord injury that my doctor thinks I should know about before we settle on a long-term bowel care routine?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Blood Pressure Change During Bowel Care
Timeframe: Measured continuously during bowel care (approximately one hour) on two occasions within 28 days.