Bowel Care and Cardiovascular Function After Spinal Cord Injury

NCT ID: NCT01567605

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2018-12-31

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.

Conditions

Spinal Cord Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Lidocaine lubricant

Intervention Type: DRUG

Subjects using this intervention will receive 30 mL of Lidocaine hydrochloride jelly (2%)

Placebo lubricant

Intervention Type: OTHER

Subjects using this intervention will receive 30 mL of placebo lubricant (no topical anesthetic)

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.

Group Type: PLACEBO_COMPARATOR

Lidocaine lubricant

Intervention Type: DRUG

Subjects using this intervention will receive 30 mL of Lidocaine hydrochloride jelly (2%)

Placebo lubricant

Intervention Type: OTHER

Subjects using this intervention will receive 30 mL of placebo lubricant (no topical anesthetic)

Interventions

Lidocaine lubricant

Subjects using this intervention will receive 30 mL of Lidocaine hydrochloride jelly (2%)

Intervention Type: DRUG

Placebo lubricant

Subjects using this intervention will receive 30 mL of placebo lubricant (no topical anesthetic)

Intervention Type: OTHER

Other Intervention Names

xylocaine jelly (2%) AstraZeneca; AMG MedPro lubricating Gel

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: collaborator

Simon Fraser University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Victoria Claydon

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Victoria E Claydon, PhD

Role: PRINCIPAL_INVESTIGATOR

Simon Fraser University and International Collaboration on Repair Discoveries (ICORD)

Locations

Simon Fraser University

Burnaby, British Columbia, Canada

International Collaboration on Repair Discoveries

Vancouver, British Columbia, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2011s0593

Identifier Type: -

Identifier Source: org_study_id