Bowel Care and Cardiovascular Function After Spinal Cord Injury

May 12, 2022 updated by: Dr. Victoria Claydon, Simon Fraser University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Burnaby, British Columbia, Canada, V5A 1S6
        • Simon Fraser University
      • Vancouver, British Columbia, Canada, V5Z1M9
        • International Collaboration On Repair Discoveries

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Lidocaine lubricant (then placebo)
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.
Drug: Lidocaine lubricant
Subjects using this intervention will receive 30 mL of Lidocaine hydrochloride jelly (2%)
Other Names:
  • xylocaine jelly (2%) AstraZeneca
Other: Placebo lubricant
Subjects using this intervention will receive 30 mL of placebo lubricant (no topical anesthetic)
Other Names:
  • AMG MedPro lubricating Gel
PLACEBO_COMPARATOR: Placebo lubricant (then lidocaine)
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.
Drug: Lidocaine lubricant
Subjects using this intervention will receive 30 mL of Lidocaine hydrochloride jelly (2%)
Other Names:
  • xylocaine jelly (2%) AstraZeneca
Other: Placebo lubricant
Subjects using this intervention will receive 30 mL of placebo lubricant (no topical anesthetic)
Other Names:
  • AMG MedPro lubricating Gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measured continuously during bowel care (approximately one hour) on two occasions within 28 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The exact duration of bowel care will be noted on two days within a 28 day period
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. 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.
Measured by questionnaire (approximately 15 minutes) after bowel care on two occasions within 28 days.
Heart Beat Abnormalities During Bowel Care (Number of Participants With Heart Beat Abnormalities)
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.
Measured continuously during bowel care (approximately one hour) on two occasions within 28 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Simon Fraser University

Collaborators

University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ACTUAL)

December 1, 2018

Study Completion (ACTUAL)

December 1, 2018

Study Registration Dates

First Submitted

March 23, 2012

First Submitted That Met QC Criteria

March 28, 2012

First Posted (ESTIMATE)

March 30, 2012

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

May 12, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011s0593

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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