search
Back to results

Bowel Care and Cardiovascular Function After Spinal Cord Injury

Primary Purpose

Spinal Cord Injury

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Lidocaine lubricant
Placebo lubricant
Sponsored by
Simon Fraser University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring spinal cord injury, autonomic dysreflexia, blood pressure, bowel care management, defecation

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Simon Fraser University
  • International Collaboration on Repair Discoveries

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lidocaine lubricant (then placebo)

Placebo lubricant (then lidocaine)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Duration of Bowel Care Routine
The duration of bowel care routine will be recorded on two occasions within 28 days.
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.
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.

Full Information

First Posted
March 23, 2012
Last Updated
May 12, 2022
Sponsor
Simon Fraser University
Collaborators
University of British Columbia
search

1. Study Identification

Unique Protocol Identification Number
NCT01567605
Brief Title
Bowel Care and Cardiovascular Function After Spinal Cord Injury
Official Title
Bowel Care and Cardiovascular Function After Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Simon Fraser University
Collaborators
University of British Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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 compared to a placebo lubricant improves the symptoms and signs of autonomic dysreflexia during bowel care in people with spinal cord injury.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
spinal cord injury, autonomic dysreflexia, blood pressure, bowel care management, defecation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine lubricant (then placebo)
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo lubricant (then lidocaine)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lidocaine lubricant
Other Intervention Name(s)
xylocaine jelly (2%) AstraZeneca
Intervention Description
Subjects using this intervention will receive 30 mL of Lidocaine hydrochloride jelly (2%)
Intervention Type
Other
Intervention Name(s)
Placebo lubricant
Other Intervention Name(s)
AMG MedPro lubricating Gel
Intervention Description
Subjects using this intervention will receive 30 mL of placebo lubricant (no topical anesthetic)
Primary Outcome Measure Information:
Title
Blood Pressure Change During Bowel Care
Description
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.
Time Frame
Measured continuously during bowel care (approximately one hour) on two occasions within 28 days.
Secondary Outcome Measure Information:
Title
Duration of Bowel Care Routine
Description
The duration of bowel care routine will be recorded on two occasions within 28 days.
Time Frame
The exact duration of bowel care will be noted on two days within a 28 day period
Title
Cardiovascular Symptoms During Bowel Care
Description
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.
Time Frame
Measured by questionnaire (approximately 15 minutes) after bowel care on two occasions within 28 days.
Title
Heart Beat Abnormalities During Bowel Care (Number of Participants With Heart Beat Abnormalities)
Description
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.
Time Frame
Measured continuously during bowel care (approximately one hour) on two occasions within 28 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victoria E Claydon, PhD
Organizational Affiliation
Simon Fraser University and International Collaboration on Repair Discoveries (ICORD)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Simon Fraser University
City
Burnaby
State/Province
British Columbia
ZIP/Postal Code
V5A 1S6
Country
Canada
Facility Name
International Collaboration on Repair Discoveries
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z1M9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Bowel Care and Cardiovascular Function After Spinal Cord Injury

We'll reach out to this number within 24 hrs