CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 13 enrolled
Drug / intervention
Lidocaine lubricant +1 moredrug
Likely dose
Lidocaine lubricant 30 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01567605
NCT01567605Phase 4Completed

Bowel Care and Cardiovascular Function After Spinal Cord Injury

Simon Fraser University·interventional·Posted Mar 30, 2012·Updated Feb 8, 2023

In Brief

A Phase 4 clinical trial evaluating Lidocaine lubricant and Placebo lubricant for Spinal Cord Injury. Completed, enrolled 13 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 30, 2012
Enrollment StartMar 1, 2012
Primary CompletionDec 1, 2018
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 14.3 years ago

Interventions

Lidocaine lubricantdrug

Subjects using this intervention will receive 30 mL of Lidocaine hydrochloride jelly (2%)

Placebo lubricantother

Subjects using this intervention will receive 30 mL of placebo lubricant (no topical anesthetic)