Tsui Test as a Predictor of Bupivacaine Consumption in Labour Epidurals

NCT ID: NCT00792311

Last Updated: 2010-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2009-08-31

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.

Conditions

Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Tsui test

Tsui test administration.

Group Type: EXPERIMENTAL

Tsui test

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mount Sinai Hospital

Principal Investigators

Jose CA Carvalho, MD

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Locations

Mount Sinai Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

08-02

Identifier Type: -

Identifier Source: org_study_id