Bowel Care and Cardiovascular Function After Spinal Cord Injury
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Purpose
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 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 | Intervention | Phase |
|---|---|---|
|
Spinal Cord Injury |
Drug: Lidocaine lubricant Other: Placebo lubricant |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Bowel Care and Cardiovascular Function After Spinal Cord Injury |
- Blood pressure change during bowel care [ Time Frame: Measured continuously during bowel care (approximately one hour) on two occasions within 28 days. ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 13 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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: Regular lubricant
In this arm, subjects will use regular lubricant in their normal bowel routine
|
Other: Placebo lubricant
Placebo lubricant (no topical anesthetic) 30 mL
Other Name: AMG MedPro lubricating Gel
|
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 improves the symptoms and signs of autonomic dysreflexia during bowel care in people with spinal cord injury.
Eligibility| Ages Eligible for Study: | 19 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Victoria E Claydon, PhD | 778-782-8513 | victoria_claydon@sfu.ca |
| Contact: Jessica A Inskip, MSc | 778-782-8560 | jinskip@sfu.ca |
| Canada, British Columbia | |
| Simon Fraser University | Recruiting |
| Burnaby, British Columbia, Canada, V5A 1S6 | |
| Contact: Jessica A Inskip, MSc 7787828560 jinskip@sfu.ca | |
| Contact: Maureen McGrath, RN 604-765-9287 Maureen.McGrath@vch.ca | |
| Principal Investigator: Victoria E Claydon, PhD | |
| Sub-Investigator: Jessica A Inskip, MSc | |
| Sub-Investigator: Maureen McGrath, RN | |
| International Collaboration on Repair Discoveries | Recruiting |
| Vancouver, British Columbia, Canada, V5Z1M9 | |
| Contact: Jessica A Inskip, MSc 604-809-9021 jinskip@sfu.ca | |
| Contact: Victoria E Claydon, PhD 778-782-8513 victoria_claydon@sfu.ca | |
| Principal Investigator: Victoria E Claydon, PhD | |
| Sub-Investigator: Jessica A Inskip, MSc | |
| Sub-Investigator: Maureen McGrath, RN | |
| Principal Investigator: | Victoria E Claydon, PhD | Simon Fraser University and International Collaboration on Repair Discoveries (ICORD) |
More Information
No publications provided
| Responsible Party: | Dr. Victoria Claydon, Assistant Professor, Simon Fraser University |
| ClinicalTrials.gov Identifier: | NCT01567605 History of Changes |
| Other Study ID Numbers: | 2011s0593 |
| Study First Received: | March 23, 2012 |
| Last Updated: | March 28, 2012 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Simon Fraser University:
|
spinal cord injury autonomic dysreflexia blood pressure bowel care management defecation |
Additional relevant MeSH terms:
|
Spinal Cord Injuries Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System Wounds and Injuries Lidocaine Anesthetics, Local Anesthetics |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Anti-Arrhythmia Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 16, 2013