Spinal Cord Injury
Conditions
Keywords
spinal cord injury, autonomic dysreflexia, blood pressure, bowel care management, defecation
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.
Interventions
Subjects using this intervention will receive 30 mL of Lidocaine hydrochloride jelly (2%)
OTHERPlacebo lubricant
Subjects using this intervention will receive 30 mL of placebo lubricant (no topical anesthetic)
Sponsors
University of British Columbia
Simon Fraser University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure Change During Bowel Care | Measured continuously during bowel care (approximately one hour) on two occasions within 28 days. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Bowel Care Routine | The exact duration of bowel care will be noted on two days within a 28 day period | The duration of bowel care routine will be recorded on two occasions within 28 days. |
| Cardiovascular Symptoms During Bowel Care | Measured by questionnaire (approximately 15 minutes) after bowel care on two occasions within 28 days. | Cardiovascular symptoms will be recorded using a questionnaire on two occasions within 28 days. The questionnaire takes approximately 15 minutes to complete. The symptom score rated 13 measures (from 0-4) based on the frequency of symptoms experiences with a possible score ranging from 0-52. High scores denote more severe symtoms. |
| 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. | 3-lead electrocardiogram will be recorded throughout the duration of bowel care on two occasions within 28 days, for up to one hour on each occasion. |
Countries
Canada
Participant flow
Recruitment details
Participants (n=13) were recruited using a multi-method approach. Print advertisements were circulated through our community partner, Spinal Cord Injury British Columbia, via their quarterly publication, The Spin, and online advertisements were posted through our institutional website (www.icord.org).
Pre-assignment details
All participants met eligibility criteria and were randomised to treatment in a crossover manner.
Participants by arm
| Arm | Count |
|---|---|
| Lidocaine Lubricant Then Placebo Lubricant In this arm, subjects will use lidocaine lubricant in their normal bowel care routine on test day one and placebo lubricant on test day two.
Lidocaine lubricant: Subjects using this intervention will receive 30 mL of Lidocaine hydrochloride jelly (2%).
Placebo lubricant: Subjects using this intervention will receive 30 mL of placebo lubricant (no topical anesthetic) | 7 |
| Placebo Lubricant Then Lidocaine Lubricant In this arm, subjects will use placebo lubricant (AMG MedPro lubricating gel) in their normal bowel care routine on test day one and lidocaine lubricant on test day two.
Placebo lubricant: Subjects using this intervention will receive 30 mL of placebo lubricant (no topical anesthetic)
Lidocaine lubricant: Subjects using this intervention will receive 30 mL of Lidocaine hydrochloride jelly (2%) | 6 |
| Total | 13 |
Baseline characteristics
| Characteristic | Placebo Lubricant Then Lidocaine Lubricant | Total | Lidocaine Lubricant Then Placebo Lubricant |
|---|---|---|---|
| Age, Continuous | 47 years STANDARD_DEVIATION 14 | 44 years STANDARD_DEVIATION 11.9 | 42 years STANDARD_DEVIATION 11 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Canada | 6 participants | 13 participants | 7 participants |
| Sex: Female, Male Female | 1 Participants | 4 Participants | 3 Participants |
| Sex: Female, Male Male | 5 Participants | 9 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 6 |
| other Total, other adverse events | 0 / 7 | 0 / 6 |
| serious Total, serious adverse events | 0 / 7 | 0 / 6 |
Outcome results
Primary
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.
Time frame: Measured continuously during bowel care (approximately one hour) on two occasions within 28 days.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lidocaine Lubricant | Blood Pressure Change During Bowel Care | 90.5 mmHg | Standard Error 13.4 |
| Placebo Lubricant | Blood Pressure Change During Bowel Care | 80 mmHg | Standard Error 8.7 |
Secondary
Cardiovascular Symptoms During Bowel Care
Cardiovascular symptoms will be recorded using a questionnaire on two occasions within 28 days. The questionnaire takes approximately 15 minutes to complete. The symptom score rated 13 measures (from 0-4) based on the frequency of symptoms experiences with a possible score ranging from 0-52. High scores denote more severe symtoms.
Time frame: Measured by questionnaire (approximately 15 minutes) after bowel care on two occasions within 28 days.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lidocaine Lubricant | Cardiovascular Symptoms During Bowel Care | 7.6 score on a scale | Standard Error 1.5 |
| Placebo Lubricant | Cardiovascular Symptoms During Bowel Care | 7.0 score on a scale | Standard Error 2 |
Secondary
Duration of Bowel Care Routine
The duration of bowel care routine will be recorded on two occasions within 28 days.
Time frame: The exact duration of bowel care will be noted on two days within a 28 day period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lidocaine Lubricant | Duration of Bowel Care Routine | 79.1 minutes | Standard Error 10 |
| Placebo Lubricant | Duration of Bowel Care Routine | 57.7 minutes | Standard Error 6.3 |
Secondary
Heart Beat Abnormalities During Bowel Care (Number of Participants With Heart Beat Abnormalities)
3-lead electrocardiogram will be recorded throughout the duration of bowel care on two occasions within 28 days, for up to one hour on each occasion.
Time frame: Measured continuously during bowel care (approximately one hour) on two occasions within 28 days.
Population: Proportion of participants reporting symptoms of palpitations during bowel care on each test day.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lidocaine Lubricant | Heart Beat Abnormalities During Bowel Care (Number of Participants With Heart Beat Abnormalities) | 3 Participants |
| Placebo Lubricant | Heart Beat Abnormalities During Bowel Care (Number of Participants With Heart Beat Abnormalities) | 2 Participants |