Clinical trial NCT01567605
Conditions: Spinal Cord Injury
Keywords: spinal cord injury autonomic dysreflexia blood pressure bowel care management defecation
Sponsor: Simon Fraser University
Start date: 2012-03-01; Completion date: 2018-12-01
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

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.

Arms: arm 1: 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. arm 2: 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.
Interventions: intervention 1: Lidocaine lubricant intervention 2: Placebo lubricant
Intervention descriptions: intervention 1: Subjects using this intervention will receive 30 mL of Lidocaine hydrochloride jelly (2%) intervention 2: Subjects using this intervention will receive 30 mL of placebo lubricant (no topical anesthetic)

Protocol documents:
Prot_SAP_000.pdf: 
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BOWEL CARE AND CARDIOVASCULAR FUNCTION AFTER SPINAL CORD INJURY 
This description of the study protocol and statistical analysis plan is taken from the published article 
containing all study details: 
V-E.M. Lucci, M.S. McGrath, J.A. Inskip, S. Sarveswaran, R. Willms, V.E. Claydon (2020) Clinical 
recommendations for use of lidocaine lubricant during bowel care after spinal cord injury prolong care 
routines and worsen autonomic dysreflexia: results from a randomised clinical trial. Spinal Cord, 58: 430-
440. (www.nature.com/articles/s41393-019-0381-2) 
MATERIALS AND METHODS 
Ethical Approval  
This study was approved by the Department of Research Ethics at Simon Fraser University and conforms 
to the principles outlined in the Declaration of Helsinki [25]. Participants provided written informed consent 
and the trial was registered (Clinical.Tials.gov #NCT01567605).  
Participants 
Participants 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). 
Eligible participants were individuals aged >18 years of age with chronic (>1 year) traumatic high level 
(T6 or above) SCI, who had an established bowel care routine, and a prior history of AD. Individuals were 
excluded if they had a medical/psychiatric condition or substance abuse disorder, used a ventilator, had a 
colostomy, or did not perform regular bowel care for any reason. Additional exclusion criteria included 
skin breakdown in the areas receiving pressure during the bowel program, inability to communicate in 
English, use of medicines containing lidocaine, allergy to lidocaine, and pregnancy.  
Our primary outcome measure was the difference in systolic arterial pressure between the placebo and 
lidocaine conditions. We determined a meaningful difference to detect in blood pressure between the two 
study arms of 10mmHg (based on previous unpublished observations from our lab). With a power of 0.8 
and alpha of 0.05, we determined a sample size of 13 individuals would be necessary to ensure statistical 
confidence in our ability to detect differences in this primary outcome measure.  
Experimental Procedure 
We conducted a registered double-blind placebo-controlled crossover clinical trial where participants were 
randomised to a series of two treatments: lidocaine lubricant (Xylocaine 2%) and standard lubricant (KY 
Jelly; placebo) on two consecutive at-home visits (Figure 1). The sequence of conditions was determined 
by random draw, using a complete randomised design, by a researcher external to the research team; seven 
participants were randomised to the lidocaine arm of the study first, and six to the placebo arm of the study 
first. Testing took place between August 2016 and October 2018. 
Prior to the first visit, participants completed a questionnaire about their bowel management and general 
bowel continence [5]. On each visit, participants were fitted with a standard three-lead electrocardiogram 
(ECG; lead II) and a non-invasive beat-to-beat finger blood pressure monitor (Finometer Midi, Finapres 
Medical Systems [FMS], Amsterdam, Netherlands). After a 10-minute baseline recording (sampling rate 
200Hz) participants inserted 5mL of lubricant into the rectum using a specialised device (Lube Launcher 
XL, CleanStream, Huntington Beach, USA) to ensure that a minimum amount of lubricant was 
administered. Following insertion of the lubricant, participants waited 5-min before starting bowel care (to 
allow for mucosal absorption of lidocaine, which has a typical onset of action of 3-5 minutes). Participants 
were then provided with an additional 15mL of lubricant and asked to perform their bowel care routine as 


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usual, replacing their normal lubricant with the lubricant provided for that day. The maximum 
recommended dosage of lidocaine is 600mg/12 hour. The dosage provided (20ml of 2% lidocaine) is 
equivalent to 400mg. The 20ml volume was determined based on discussion with bowel care providers and 
individuals with SCI concerning their typical lubricant needs. This dosing strategy is in line with other 
similar studies. Given the typical half-life of lidocaine (1.5-2 hours) we are confident there was optimal 
dosing throughout the duration of bowel care. 
Five minutes after insertion of the test lubricant, a timer was started and the participant commenced their 
usual care routine. Bowel care routines were not standardised because the primary interest was to 
investigate the real-world feasibility and impact of this clinical recommendation in a community setting 
with usual participant care routines. When the participant signalled the end of their care routine (defined as 
the time when bowel evacuation was completed, prior to cleaning), the timer was stopped, and the bowel 
care duration noted. The cardiovascular monitoring equipment was then removed. Participants then 
completed a questionnaire specific to their bowel care on that day, reporting the method of bowel care 
employed as well as the severity of cardiovascular symptoms experienced [5]. Self-reported symptoms of 
AD were determined as described previously [5]. Two participants chose not to complete the post-bowel 
care questionnaire.  
Autonomic dysfunction 
Severity of autonomic dysfunction was determined through spectral analyses of low-frequency systolic 
arterial pressure variability (LF SAP). LF SAP oscillations (~0.1Hz) reflect sympathetic control of the 
vasculature, and thus indicate the presence or absence of autonomic cardiovascular control following SCI 
[26]. Participants with LF SAP lower than 3.75mmHg2 were determined to have autonomically-complete 
injuries.  
Cardiac rate and rhythm analyses 
Electrocardiogram data were visually inspected offline after completion of the study. The number of beats 
that met criteria for bradycardia (<60bpm) and tachycardia (>100bpm) was determined during baseline and 
bowel care, and expressed as a percentage of the total number of beats in the corresponding phase. In 
addition, each beat was classified as either sinus rhythm, or not, and any arrhythmia or conduction 
abnormalities noted.  
Data analyses 
Beat-to-beat systolic (SAP) and diastolic (DAP) arterial pressures were extracted throughout the testing 
period. Mean arterial pressure (MAP) was calculated as DAP + 1/3 x (SAP-DAP). Heart rate was 
determined from the R-R interval of the ECG. Stroke volume (SV) and cardiac output (Q) were determined 
using Modelflow [27,28], and total peripheral resistance (TPR) calculated as MAP / Q. Data were collected 
at a sampling frequency of 200 Hz and averaged over 5 successive beats. All parameters were extracted for 
the entire duration of baseline and bowel care, as well as for only the first 25 minutes of bowel care. 
Maximal responses were also determined during bowel care regardless of the time at which they occurred 
(Parametermax). AD was defined as an increase in SAPmax of at least 20mmHg [29]  compared to baseline. 
The overall burden of AD was determined from the area under the SAP curve (the product of SAP and heart 
beat). 
Statistical analyses 
Data processing was performed using R (Version 3.3.3) and RStudio (Version 1.1.453). Statistical analyses 
were performed using Sigmaplot 14 (Systat Software Inc., San Jose, CA). Data were tested for normality 
and parametric or non-parametric assumptions were used as appropriate. Comparisons of cardiovascular 
outcomes and symptoms between conditions (lidocaine and placebo) and test phases (baseline and during 
bowel care) were performed using two-way repeated measures ANOVA. Spearman rank correlations and 


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linear regressions were used to assess relationships between variables. Fisher’s exact test was used to 
evaluate differences in proportions of responses between test conditions. Student t tests were used to 
compare responses between placebo and lidocaine conditions (e.g. time to complete bowel care). Statistical 
significance was assumed at p<0.05. Where appropriate, data are represented as mean ± standard error, 
unless otherwise stated. Researchers, participants, care providers, and those analysing the data were blinded 
to the test condition. Researchers were unblinded just prior to statistical analyses.