NCT00464841

Brief Summary

Combined spinal epidural anesthesia (CSE) is a very effective technique to provide labor analgesia. One of the disadvantages of this technique is the delay in recognizing an error in the position of the epidural catheter because of the effects of the spinal component. Eventually in case of a misplaced catheter, the patient will experience pain or discomfort requiring a repeat procedure after the effect of drug given during the spinal wears off. Low current electrical stimulation test, or the Tsui test, has been used successfully to confirm catheter location in the epidural space. The investigators' objective in this study is to test the usefulness of the Tsui test to confirm the correct placement of the epidural catheter during CSE in laboring patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 24, 2007

Completed
Last Updated

September 5, 2011

Status Verified

September 1, 2011

Enrollment Period

28 days

First QC Date

April 23, 2007

Last Update Submit

September 2, 2011

Conditions

Keywords

Tsui TestCombined Spinal EpiduralLabour

Outcome Measures

Primary Outcomes (1)

  • change in current intensity required to produce a positive Tsui test after an intrathecal injection of bupivacaine

    Within 2 hours of catheter placement

Study Arms (2)

1

EXPERIMENTAL

Tsui test for combined spinal-epidural

Procedure: Combined spinal epidural

2

EXPERIMENTAL

Tsui test for intrathecal catheter

Procedure: Tsui Test for intrathecal catheter

Interventions

0.7 mL of 0.25% isobaric bupivacaine and 15mcg of fentanyl

1

0.7 mL of 0.25% isobaric bupivacaine and 15mcg of fentanyl

2

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologists (ASA) 1 or 2
  • Full term pregnancy
  • Patients requesting epidural in early labor

You may not qualify if:

  • Any contraindication to regional anesthesia
  • Allergy or hypersensitivity to lidocaine, bupivacaine, or fentanyl
  • Received prior sedatives or opioids
  • Abnormal vertebral anatomy
  • Neurological disorders with lumbar involvement
  • Patients with implanted electronic devices

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Related Publications (1)

  • Carvalho JC, Khemka R, Loke J, Tsui BC. Low-dose intrathecal local anesthetic does not increase the threshold current for the epidural stimulation test: a prospective observational trial of neuraxial analgesia in labouring women. Can J Anaesth. 2015 Mar;62(3):265-70. doi: 10.1007/s12630-014-0291-x. Epub 2014 Dec 11.

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jose CA Carvalho, MD, PhD

    MOUNT SINAI HOSPITAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2007

First Posted

April 24, 2007

Study Start

February 1, 2007

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

September 5, 2011

Record last verified: 2011-09

Locations