Bowel Care and Cardiovascular Function After Spinal Cord Injury
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Lidocaine lubricant; Placebo lubricant
Intervention type(s): Drug; Other
Intervention description(s): 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)
Other intervention name(s): xylocaine jelly (2%) AstraZeneca; AMG MedPro lubricating Gel
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: spinal cord injury; autonomic dysreflexia; blood pressure; bowel care management; defecation