Bowel Care and Cardiovascular Function After Spinal Cord Injury
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Intervention: Lidocaine lubricant; Placebo lubricant
Intervention description: Subjects using this intervention will receive 30 mL of Lidocaine hydrochloride jelly (2%); Subjects using this intervention will receive 30 mL of placebo lubricant (no topical anesthetic)
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 13.0
Sex: All
Minimum age: 19 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: spinal cord injury; autonomic dysreflexia; blood pressure; bowel care management; defecation

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.
    

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