Tsui Test as a Predictor of Bupivacaine Consumption in Labour Epidurals

Pain Clinical Trial

Official title:

Tsui Test as a Predictor of Bupivacaine Consumption in Labour Epidurals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00792311
• Other study ID #: 08-02
• Status: Completed
• Phase: N/A
• First received: November 13, 2008
• Last updated: March 25, 2010
• Start date: November 2008
• Est. completion date: August 2009

Study information

• Verified date: March 2010
• Source: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Pain

Intervention

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.

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Consumption of bupivacaine in mg/hour in the first 2 hours of epidural anesthesia		2 hours	No
Secondary	Incidence of inadequate epidural block.		2 hours	No
Secondary	Current (mA) needed to elicit motor response; 1. before test dose and 2. 5 minutes after test dose.		5 minutes	No
Secondary	Contraction pattern elicited by the Tsui test at baseline and after test dose.		5 minutes	No