Tsui Test as a Predictor of Bupivacaine Consumption in Labour Epidurals

This study has been completed.

Sponsor:

Information provided by:

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

ClinicalTrials.gov Identifier:

NCT00792311

First received: November 13, 2008

Last updated: March 25, 2010

Last verified: March 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

November 13, 2008

Last Updated Date

March 25, 2010

Start Date ^ICMJE

November 2008

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Consumption of bupivacaine in mg/hour in the first 2 hours of epidural anesthesia [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00792311 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Incidence of inadequate epidural block. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
Current (mA) needed to elicit motor response; 1. before test dose and 2. 5 minutes after test dose. [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
Contraction pattern elicited by the Tsui test at baseline and after test dose. [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Tsui Test as a Predictor of Bupivacaine Consumption in Labour Epidurals

Official Title ^ICMJE

Tsui Test as a Predictor of Bupivacaine Consumption in Labour Epidurals

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.

Detailed Description

Despite its very high success rate, the epidural technique remains a rather blind technique, and failures continue to occur. The incidence and reasons for failure are not well understood. The Tsui test is not routinely performed with each epidural catheter insertion, but rather it is used when there is suspicion about the catheter location.

In this study, the Tsui test will be performed twice during the epidural procedure, and bupivacaine consumption will be recorded for the first 2 hours.

Information gained from this study could have great impact in clinical practice, since the incidence of inadequate labor analgesia is still relatively high (10-20%), leading to maternal distress and disappointing labor experience.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Pain

Intervention ^ICMJE

Procedure: Tsui test

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.

Study Arm (s)

Experimental: Tsui test

Tsui test administration.

Intervention: Procedure: Tsui test

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

102

Completion Date

August 2009

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

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

Gender

Female

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT00792311

Other Study ID Numbers ^ICMJE

08-02

Has Data Monitoring Committee

Responsible Party

Dr. Jose C.A. Carvalho, Mount Sinai Hospital

Study Sponsor ^ICMJE

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jose CA Carvalho, MD

Mount Sinai Hospital, New York

Information Provided By

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Verification Date

March 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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