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Clinical Trials/NCT00792311
NCT00792311CompletedNot Applicable

Tsui Test as a Predictor of Bupivacaine Consumption in Labour Epidurals

Samuel Lunenfeld Research Institute, Mount Sinai Hospital2 sites in 1 country102 target enrollmentStarted: November 1, 2008Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
102
Locations
2
Primary Endpoint
Consumption of bupivacaine in mg/hour in the first 2 hours of epidural anesthesia

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Consumption of bupivacaine in mg/hour in the first 2 hours of epidural anesthesia

Time Frame: 2 hours

Secondary Outcomes

  • 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)

Investigators

Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Sponsor Class
Other

Study Sites (2)

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