Bowel Care and Cardiovascular Function After Spinal Cord Injury

NCT01567605 | Completed Phase 4 Results

• 1 other identifier: 2011s0593
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

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.

Conditions

Spinal Cord Injury

Keywords

spinal cord injury; autonomic dysreflexia; blood pressure; bowel care management; defecation

Outcome Measures

Primary Outcomes (1)

• 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.

  Measured continuously during bowel care (approximately one hour) on two occasions within 28 days.

Secondary Outcomes (3)

• Duration of Bowel Care Routine

  The exact duration of bowel care will be noted on two days within a 28 day period

• Cardiovascular Symptoms During Bowel Care

  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)

  Measured continuously during bowel care (approximately one hour) on two occasions within 28 days.

Study Arms (2)

Lidocaine lubricant (then placebo)

EXPERIMENTAL

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; Other: Placebo lubricant

Placebo lubricant (then lidocaine)

PLACEBO COMPARATOR

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; Other: Placebo lubricant

Interventions

Lidocaine lubricant DRUG

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

Also known as: xylocaine jelly (2%) AstraZeneca

Lidocaine lubricant (then placebo); Placebo lubricant (then lidocaine)

Placebo lubricant OTHER

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

Also known as: AMG MedPro lubricating Gel

Lidocaine lubricant (then placebo); Placebo lubricant (then lidocaine)

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• traumatic spinal cord injury at least one year ago
• regular bowel care routine (at least four weeks)

You may not qualify if:

• 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

Sponsors & Collaborators

• Simon Fraser University: lead
• University of British Columbia: collaborator

Study Sites (2)

Simon Fraser University

Burnaby, British Columbia, V5A 1S6, Canada

Location

International Collaboration on Repair Discoveries

Vancouver, British Columbia, V5Z1M9, Canada

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Autonomic Dysreflexia

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Autonomic Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr Victoria Claydon (Principal Investigator)
• Organization: Simon Fraser University

victoria_claydon@sfu.ca

7787828513

Study Officials

• Victoria E Claydon, PhD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 23, 2012
• First Posted: March 30, 2012
• Study Start: March 1, 2012
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 8, 2023
• Results First Posted: February 8, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)