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Usefulness of the Tsui Test in Combined Spinal-Epidural Analgesia in Labour

Primary Purpose

Labor Pain

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Combined spinal epidural
Tsui Test for intrathecal catheter
Sponsored by
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Labor Pain focused on measuring Tsui Test, Combined Spinal Epidural, Labour

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Mount Sinai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Tsui test for combined spinal-epidural

Tsui test for intrathecal catheter

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 23, 2007
Last Updated
September 2, 2011
Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00464841
Brief Title
Usefulness of the Tsui Test in Combined Spinal-Epidural Analgesia in Labour
Official Title
Can the Tsui Test be Used to Test the Placement of Epidural Catheters Following the Intrathecal Component of a Combined Spinal-epidural Technique Used for Labor Analgesia?
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
CSE is a widely used technique to provide analgesia in laboring patients. One of the disadvantages of the CSE is the delay in recognizing the mal-position of the epidural catheter, which is initially masked due to the effects of the spinal component. A mal-positioned epidural catheter can cause unnecessary maternal discomfort and dissatisfaction, as it requires a repeat procedure when the effect of spinal drug wears off. Additionally, in the event of emergency caesarean delivery, it would be advantageous to know that the catheter is properly placed. Low current electrical stimulation test, or the Tsui test, has been used successfully to confirm catheter location in the epidural space. Our 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. Two groups of patients will be studied. In the first group, after the placement of the epidural catheter and noting the electric current required to elicit a motor response (maximum current used is 20 mA), a spinal needle is introduced one inter vertebral space below the space where the epidural catheter is inserted and 0.7 ml of 0.25% isobaric bupivacaine and 15 mcg of fentanyl is injected intrathecally. The epidural catheter is then re-stimulated and the magnitude of the current required to reproduce the motor response is noted. The stimulation is repeated after 5, 10, and 15 minutes. The second group consists of patients with accidental dural puncture. An intrathecal catheter is inserted and the Tsui test performed (maximum current used is 2 mA), followed by the injection of same mixture of local anesthetic and opioid as used in the first group. The Tsui test is repeated at 5, 10 and 15 minute intervals, similar to what is done in the epidural group. After 15 minutes, patients in both groups are managed as per departmental policy. In both the groups, the Tsui test will be repeated after 120 minutes during the maintenance of labor analgesia to determine the change in intensity of current required to elicit the motor response.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
Tsui Test, Combined Spinal Epidural, Labour

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Tsui test for combined spinal-epidural
Arm Title
2
Arm Type
Experimental
Arm Description
Tsui test for intrathecal catheter
Intervention Type
Procedure
Intervention Name(s)
Combined spinal epidural
Intervention Description
0.7 mL of 0.25% isobaric bupivacaine and 15mcg of fentanyl
Intervention Type
Procedure
Intervention Name(s)
Tsui Test for intrathecal catheter
Intervention Description
0.7 mL of 0.25% isobaric bupivacaine and 15mcg of fentanyl
Primary Outcome Measure Information:
Title
change in current intensity required to produce a positive Tsui test after an intrathecal injection of bupivacaine
Time Frame
Within 2 hours of catheter placement

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists (ASA) 1 or 2 Full term pregnancy Patients requesting epidural in early labor Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose CA Carvalho, MD, PhD
Organizational Affiliation
MOUNT SINAI HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25501494
Citation
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.
Results Reference
derived

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Usefulness of the Tsui Test in Combined Spinal-Epidural Analgesia in Labour

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