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

November 13, 2008
March 25, 2010
November 2008
August 2009   (final data collection date for primary outcome measure)
Consumption of bupivacaine in mg/hour in the first 2 hours of epidural anesthesia [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00792311 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Tsui Test as a Predictor of Bupivacaine Consumption in Labour Epidurals
Tsui Test as a Predictor of Bupivacaine Consumption in Labour Epidurals

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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Pain
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.
Experimental: Tsui test
Tsui test administration.
Intervention: Procedure: Tsui test
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
102
August 2009
August 2009   (final data collection date for primary outcome measure)

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
Female
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00792311
08-02
No
Dr. Jose C.A. Carvalho, Mount Sinai Hospital
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Not Provided
Principal Investigator: Jose CA Carvalho, MD Mount Sinai Hospital, New York
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
March 2010

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