Bowel Care and Cardiovascular Function After Spinal Cord Injury

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by Simon Fraser University
Sponsor:
Collaborator:
University of British Columbia
Information provided by (Responsible Party):
Dr. Victoria Claydon, Simon Fraser University
ClinicalTrials.gov Identifier:
NCT01567605
First received: March 23, 2012
Last updated: March 28, 2012
Last verified: March 2012
  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

Resource links provided by NLM:


Further study details as provided by Simon Fraser University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01567605

Contacts
Contact: Victoria E Claydon, PhD 778-782-8513 victoria_claydon@sfu.ca
Contact: Jessica A Inskip, MSc 778-782-8560 jinskip@sfu.ca

Locations
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         
Sponsors and Collaborators
Simon Fraser University
University of British Columbia
Investigators
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
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
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 July 10, 2014