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Phase 4 Completed N=13 Randomized Quadruple-blind Treatment

Bowel Care and Cardiovascular Function After Spinal Cord Injury

Source: ClinicalTrials.gov NCT01567605 ↗
Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcomePrimary: Blood Pressure Change During Bowel Care — 90.5; 80 mmHg
◆ Published Evidence
No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Blood Pressure Change During Bowel Care
90.5; 80
SECONDARY
Duration of Bowel Care Routine
79.1; 57.7
SECONDARY
Cardiovascular Symptoms During Bowel Care
7.6; 7.0
SECONDARY
Heart Beat Abnormalities During Bowel Care (Number of Participants With Heart Beat Abnormalities)
3; 2

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01567605). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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