Tsui Test as a Predictor of Bupivacaine Consumption in Labour Epidurals
1 other identifier
interventional
102
1 country
1
Brief Summary
Low current electrical stimulation test, also called the Tsui test, has been used successfully to confirm the catheter location in the epidural space in various patient populations. The results of this study will show whether or not doing a Tsui test can predict inadequate epidural analgesia early in the course of placing the epidural, so that the appropriate measures could be applied immediately upon gathering unfavorable results.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable pain
Started Nov 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 13, 2008
CompletedFirst Posted
Study publicly available on registry
November 17, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedMarch 26, 2010
March 1, 2010
9 months
November 13, 2008
March 25, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Consumption of bupivacaine in mg/hour in the first 2 hours of epidural anesthesia
2 hours
Secondary Outcomes (3)
Incidence of inadequate epidural block.
2 hours
Current (mA) needed to elicit motor response; 1. before test dose and 2. 5 minutes after test dose.
5 minutes
Contraction pattern elicited by the Tsui test at baseline and after test dose.
5 minutes
Study Arms (1)
Tsui test
EXPERIMENTALTsui test administration.
Interventions
The stimulator is set at frequency of 1Hz with 200ms pulse width and the current output ranging from 0 to 20 mA. The current output will be carefully increased from zero until motor activity is detected up to a maximum of 20 mA.
Eligibility Criteria
You may qualify if:
- Women over 18 years of age requesting an epidural for labor and delivery
- Cervix dilated 0-5 cm and pain VAS\>6
- Able to communicate in English
- Informed consent
You may not qualify if:
- Refusal to provide written informed consent
- Patients unable to communicate in English
- Contraindication to regional anesthesia
- Allergy or hypersensitivity to lidocaine, bupivacaine or fentanyl
- Sedatives or opioids received prior to insertion of epidural catheter
- Abnormal vertebral anatomy, such as previous spine surgery and scoliosis
- Coexisting neurological disorders
- Patients with implanted electronic devices
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jose CA Carvalho, MD
MOUNT SINAI HOSPITAL
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 13, 2008
First Posted
November 17, 2008
Study Start
November 1, 2008
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
March 26, 2010
Record last verified: 2010-03