Spinal Cord InjuryPhase 4NCT01567605
Bowel Care and Cardiovascular Function After Spinal Cord Injury
A Phase 4 study testing Lidocaine lubricant in people with Spinal Cord Injury, run by Simon Fraser University at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Lidocaine lubricant
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 2 sitesCanada
- Study dates
- Mar 2012to Dec 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- traumatic spinal cord injury at least one year ago
- regular bowel care routine (at least four weeks)
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Simon Fraser University
Burnaby, British Columbia, V5A 1S6
International Collaboration on Repair Discoveries
Vancouver, British Columbia, V5Z1M9
About this study
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.
Read the 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.
- Conditions
- Spinal Cord Injury
- Being tested
- Lidocaine lubricant, Placebo lubricant
- Keywords
- spinal cord injury, autonomic dysreflexia, blood pressure, bowel care management, defecation
- Medical subject headings
- Spinal Cord Injuries, Autonomic Dysreflexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine lubricantDrug
Also called xylocaine jelly (2%) AstraZeneca
Subjects using this intervention will receive 30 mL of Lidocaine hydrochloride jelly (2%)
Placebo lubricantOther
Also called AMG MedPro lubricating Gel
Subjects using this intervention will receive 30 mL of placebo lubricant (no topical anesthetic)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Lidocaine lubricant; Other: Placebo lubricant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured continuously during bowel care (approximately one hour) on two occasions within 28 days.
Secondary outcomes (3)
Duration of Bowel Care Routine
The duration of bowel care routine will be recorded on two occasions within 28 days.
Measured: The exact duration of bowel care will be noted on two days within a 28 day period
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.
Measured: 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)
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.
Measured: Measured continuously during bowel care (approximately one hour) on two occasions within 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Simon Fraser University
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia
- Responsible party
- Principal investigator, Dr. Victoria Claydon, Simon Fraser University
- Investigators
- Victoria E Claydon, PhD, Principal investigator, Simon Fraser University and International Collaboration on Repair Discoveries (ICORD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01567605
- Sponsor's protocol ID
- 2011s0593
- Status last verified
- May 2022
- First submitted
- 23 Mar 2012
- Last updated
- 8 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bowel Care and Cardiovascular Function After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT01567605
- Acronym / sponsor ID
- 2011s0593
- Conditions
- Spinal Cord Injury
- Keywords
- spinal cord injury, autonomic dysreflexia, blood pressure, bowel care management, defecation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Simon Fraser UniversityUniversity, hospital or other
- Collaborators
- University of British Columbia
- Study start
- Mar 2012
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 30 Mar 2012 (estimated)
- Results
- Posted 8 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine lubricant (then placebo) | Experimental | Drug: Lidocaine lubricant, Other: Placebo lubricantIn 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. |
| Placebo lubricant (then lidocaine) | Placebo comparator | Drug: Lidocaine lubricant, Other: Placebo lubricantIn 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. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- traumatic spinal cord injury at least one year ago
- regular bowel care routine (at least four weeks)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine lubricantAlso: xylocaine jelly (2%) AstraZenecaSubjects using this intervention will receive 30 mL of Lidocaine hydrochloride jelly (2%) | Drug | Lidocaine lubricant (then placebo), Placebo lubricant (then lidocaine) |
| Placebo lubricantAlso: AMG MedPro lubricating GelSubjects using this intervention will receive 30 mL of placebo lubricant (no topical anesthetic) | Other | Lidocaine lubricant (then placebo), Placebo lubricant (then lidocaine) |
Primary outcome
Blood Pressure Change During Bowel Care
Time frame: 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.
3 secondary outcomes
Duration of Bowel Care Routine
Time frame: The exact duration of bowel care will be noted on two days within a 28 day period
Cardiovascular Symptoms During Bowel Care
Time frame: 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)
Time frame: Measured continuously during bowel care (approximately one hour) on two occasions within 28 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victoria E Claydon, PhD principal investigator
Simon Fraser University and International Collaboration on Repair Discoveries (ICORD)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine lubricant in people with Spinal Cord Injury, run by Simon Fraser University at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure Change During Bowel Care (time frame: Measured continuously during bowel care (approximately one hour) on two occasions within 28 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.