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Trial record 41 of 292 for:    Recruiting, Not yet recruiting, Available Studies | "Spinal Cord Injuries"

Bowel Care and Cardiovascular Function After Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT01567605
Recruitment Status : Recruiting
First Posted : March 30, 2012
Last Update Posted : April 27, 2017
Sponsor:
Collaborator:
University of British Columbia
Information provided by (Responsible Party):
Dr. Victoria Claydon, Simon Fraser University

March 23, 2012
March 30, 2012
April 27, 2017
March 2012
December 2017   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01567605 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Bowel Care and Cardiovascular Function After Spinal Cord Injury
Bowel Care and Cardiovascular Function After Spinal Cord Injury

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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Spinal Cord Injury
  • Drug: Lidocaine lubricant
    Subjects using this intervention will receive 30 mL of Lidocaine hydrochloride jelly (2%)
    Other Name: xylocaine jelly (2%) AstraZeneca
  • Other: Placebo lubricant
    Subjects using this intervention will receive 30 mL of placebo lubricant (no topical anesthetic)
    Other Name: AMG MedPro lubricating Gel
  • Experimental: Lidocaine lubricant
    In this arm, subjects will use lidocaine lubricant in their normal bowel care routine (rather than standard lubricating jelly).
    Intervention: Drug: Lidocaine lubricant
  • Placebo Comparator: Placebo lubricant
    In this arm, subjects will use regular lubricant (AMG MedPro lubricating gel) in their normal bowel care routine.
    Intervention: Other: Placebo lubricant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
13
December 2017
December 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
19 Years to 80 Years   (Adult, Senior)
No
Contact: Victoria E Claydon, PhD 778-782-8513 victoria_claydon@sfu.ca
Contact: Vera-Ellen Lucci, MSc 778-782-8560 vera-ellen_lucci@sfu.ca
Canada
 
 
NCT01567605
2011s0593
No
Not Provided
Plan to Share IPD: No
Dr. Victoria Claydon, Simon Fraser University
Simon Fraser University
University of British Columbia
Principal Investigator: Victoria E Claydon, PhD Simon Fraser University and International Collaboration on Repair Discoveries (ICORD)
Simon Fraser University
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP