Trial Outcomes & Findings for Bowel Care and Cardiovascular Function After Spinal Cord Injury (NCT NCT01567605)
NCT ID: NCT01567605
Last Updated: 2023-02-08
Results Overview
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.
COMPLETED
PHASE4
13 participants
Measured continuously during bowel care (approximately one hour) on two occasions within 28 days.
2023-02-08
Participant Flow
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).
All participants met eligibility criteria and were randomised to treatment in a crossover manner.
Participant milestones
| Measure |
Lidocaine Lubricant (1 Day) Followed by Placebo Lubricant (1 Day)
In this arm, subjects will first use lidocaine lubricant in their normal bowel care routine and then standard lubricant jelly.
Lidocaine lubricant: Subjects using this intervention will receive 30 mL of Lidocaine hydrochloride jelly (2%) on test day one and 30mL of placebo lubricant jelly (AMG MedPro lubricating gel) on day two.
|
Placebo Lubricant (1 Day) Followed by Lidocaine Lubricant (1 Day)
In this arm, subjects will use placebo lubricant (AMG MedPro lubricating gel) in their normal bowel care routine on test day one followed by 30 mL of Lidocaine hydrochloride jelly (2%) on test day two.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
|
Overall Study
COMPLETED
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Lidocaine Lubricant Then Placebo Lubricant
n=7 Participants
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)
|
Placebo Lubricant Then Lidocaine Lubricant
n=6 Participants
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%)
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
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Age, Continuous
|
42 years
STANDARD_DEVIATION 11 • n=7 Participants
|
47 years
STANDARD_DEVIATION 14 • n=6 Participants
|
44 years
STANDARD_DEVIATION 11.9 • n=13 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=7 Participants
|
1 Participants
n=6 Participants
|
4 Participants
n=13 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=7 Participants
|
5 Participants
n=6 Participants
|
9 Participants
n=13 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
7 participants
n=7 Participants
|
6 participants
n=6 Participants
|
13 participants
n=13 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Lidocaine Lubricant
n=13 Participants
In this arm, subjects will use lidocaine lubricant in their normal bowel care routine (rather than standard lubricating jelly).
Lidocaine lubricant: Subjects using this intervention will receive 30 mL of Lidocaine hydrochloride jelly (2%)
|
Placebo Lubricant
n=13 Participants
In this arm, subjects will use regular lubricant (AMG MedPro lubricating gel) in their normal bowel care routine.
Placebo lubricant: Subjects using this intervention will receive 30 mL of placebo lubricant (no topical anesthetic)
|
|---|---|---|
|
Blood Pressure Change During Bowel Care
|
90.5 mmHg
Standard Error 13.4
|
80 mmHg
Standard Error 8.7
|
SECONDARY outcome
Timeframe: The exact duration of bowel care will be noted on two days within a 28 day periodThe duration of bowel care routine will be recorded on two occasions within 28 days.
Outcome measures
| Measure |
Lidocaine Lubricant
n=13 Participants
In this arm, subjects will use lidocaine lubricant in their normal bowel care routine (rather than standard lubricating jelly).
Lidocaine lubricant: Subjects using this intervention will receive 30 mL of Lidocaine hydrochloride jelly (2%)
|
Placebo Lubricant
n=13 Participants
In this arm, subjects will use regular lubricant (AMG MedPro lubricating gel) in their normal bowel care routine.
Placebo lubricant: Subjects using this intervention will receive 30 mL of placebo lubricant (no topical anesthetic)
|
|---|---|---|
|
Duration of Bowel Care Routine
|
79.1 minutes
Standard Error 10
|
57.7 minutes
Standard Error 6.3
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Lidocaine Lubricant
n=13 Participants
In this arm, subjects will use lidocaine lubricant in their normal bowel care routine (rather than standard lubricating jelly).
Lidocaine lubricant: Subjects using this intervention will receive 30 mL of Lidocaine hydrochloride jelly (2%)
|
Placebo Lubricant
n=13 Participants
In this arm, subjects will use regular lubricant (AMG MedPro lubricating gel) in their normal bowel care routine.
Placebo lubricant: Subjects using this intervention will receive 30 mL of placebo lubricant (no topical anesthetic)
|
|---|---|---|
|
Cardiovascular Symptoms During Bowel Care
|
7.6 score on a scale
Standard Error 1.5
|
7.0 score on a scale
Standard Error 2.0
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Lidocaine Lubricant
n=11 Participants
In this arm, subjects will use lidocaine lubricant in their normal bowel care routine (rather than standard lubricating jelly).
Lidocaine lubricant: Subjects using this intervention will receive 30 mL of Lidocaine hydrochloride jelly (2%)
|
Placebo Lubricant
n=11 Participants
In this arm, subjects will use regular lubricant (AMG MedPro lubricating gel) in their normal bowel care routine.
Placebo lubricant: Subjects using this intervention will receive 30 mL of placebo lubricant (no topical anesthetic)
|
|---|---|---|
|
Heart Beat Abnormalities During Bowel Care (Number of Participants With Heart Beat Abnormalities)
|
3 Participants
|
2 Participants
|
Adverse Events
Lidocaine Lubricant Then Placebo Lubricant
Placebo Lubricant Then Lidocaine Lubricant.
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Victoria Claydon (Principal Investigator)
Simon Fraser University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place