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Response Patterns to the Electric Stimulation of Epidural Catheters in Term Pregnant Women

Primary Purpose

Labor Pain

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Trans-catheter electric stimulation test
Sponsored by
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor Pain focused on measuring Tsui Test, Labour, Epidural catheter

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Women over 18 years of age requesting an epidural for labor and delivery
  • Able to communicate in English
  • Informed consent

Exclusion Criteria:

  • Refusal to provide written informed consent
  • Unable to communicate in English
  • Allergy or hypersensitivity to lidocaine, bupivacaine or fentanyl
  • Abnormal vertebral anatomy, including previous spine surgery and scoliosis
  • Coexisting neurological disorders
  • Implanted electronic devices

Sites / Locations

  • Mount Sinai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Uniport catheter

Multiport catheter

Arm Description

19 gauge uniport epidural catheter

19 gauge multiorifice epidural catheter

Outcomes

Primary Outcome Measures

Motor response pattern
Motor response pattern to the electrical stimulation of the epidural catheter, either unilateral or bilateral

Secondary Outcome Measures

Current (mA)
The current (mA) needed to elicit a motor response at control and at 5 minutes after the test dose
Sensory level
The sensory level to ice at 20 minutes following injection of the standard epidural loading dose. The sensory level will be assessed from the sacral to the thoracic levels, bilaterally
Epidural block failure
Failure of the epidural analgesia, defined as no evidence of a sensory block to ice and absent pain relief
Catheter replacement
Need for catheter replacement within 2 hours of the completion of the loading dose

Full Information

First Posted
October 9, 2014
Last Updated
February 18, 2015
Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02274467
Brief Title
Response Patterns to the Electric Stimulation of Epidural Catheters in Term Pregnant Women
Official Title
Response Patterns to the Electric Stimulation of Epidural Catheters in Term Pregnant Women: A Randomized Controlled Trial of Uniport Versus Multiport Catheters.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (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
Lumbar epidural analgesia is commonly used for labor pain relief due to its effectiveness and safety. Despite its very high success rate, the epidural technique remains a rather blind technique and failures continue to occur. The correct placement of an epidural catheter, however, remains a clinical problem, since there is no imaging technique that could be used at the bedside to determine the exact positioning of the catheter. The technique of a trans-catheter electric stimulation test (TCEST) has been successfully used to detect the proper epidural catheter location for pediatric, post-operative and laboring obstetric patients. The response to the TCEST with the uniport (single hole) epidural catheters has been well described. There is a growing body of evidence that multiport epidural catheters provide an advantage to uniport catheters, since additional ports likely allow for an enhanced distribution of the local anesthetic solution. This was shown to result in a lower incidence of inadequate analgesia, including unilateral sensory blockade and missed sensory segments. The characteristics of the TCEST response using a multiport catheter remain to be determined. The aim of this study is to compare the response patterns to the TCEST using a single port versus multiport wire reinforced epidural catheters. The hypothesis of this study is that the incidence of a bilateral response to the TCEST will be higher in the multiport catheter as compared to the uniport catheter.
Detailed Description
This will be a randomized double-blind controlled study. After recruitment of the patient, epidural anesthesia will be performed in the standard fashion employed in the investigators institution by a resident, fellow, or staff. Spinal ultrasound will be used prior to performing the epidural catheter insertion. Patients will be randomly allocated into two different groups to receive either a 19 gauge uniport catheter or a 19 gauge multiorifice catheter (Arrow Flextip plus, Arrow International Inc., Reading, PA). After securement of the catheter, the TCEST will be performed. The test will be repeated at 5 minutes, following a test dose, to determine the change in intensity of current required to elicit the motor response. Following the second testing, a loading dose of the standard anesthetic solution will be administered. The sensory level to ice will be tested at 20 minutes following injection of the loading dose of bupivacaine and fentanyl. The sensory level will be assessed from the sacral to the thoracic levels, bilaterally Failure of the epidural analgesia will be assessed, defined as no evidence of a sensory block to ice and absent pain relief. The need for catheter replacement will be determined within 2 hours of the completion of the loading dose.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Uniport catheter
Arm Type
Active Comparator
Arm Description
19 gauge uniport epidural catheter
Arm Title
Multiport catheter
Arm Type
Active Comparator
Arm Description
19 gauge multiorifice epidural catheter
Intervention Type
Device
Intervention Name(s)
Trans-catheter electric stimulation test
Other Intervention Name(s)
Tsui test
Primary Outcome Measure Information:
Title
Motor response pattern
Description
Motor response pattern to the electrical stimulation of the epidural catheter, either unilateral or bilateral
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
Current (mA)
Description
The current (mA) needed to elicit a motor response at control and at 5 minutes after the test dose
Time Frame
5 minutes
Title
Sensory level
Description
The sensory level to ice at 20 minutes following injection of the standard epidural loading dose. The sensory level will be assessed from the sacral to the thoracic levels, bilaterally
Time Frame
20 minutes
Title
Epidural block failure
Description
Failure of the epidural analgesia, defined as no evidence of a sensory block to ice and absent pain relief
Time Frame
20 minutes
Title
Catheter replacement
Description
Need for catheter replacement within 2 hours of the completion of the loading dose
Time Frame
2 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women over 18 years of age requesting an epidural for labor and delivery Able to communicate in English Informed consent Exclusion Criteria: Refusal to provide written informed consent Unable to communicate in English Allergy or hypersensitivity to lidocaine, bupivacaine or fentanyl Abnormal vertebral anatomy, including previous spine surgery and scoliosis Coexisting neurological disorders Implanted electronic devices
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Carvalho, MD
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
M5G1X5
Country
Canada

12. IPD Sharing Statement

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Response Patterns to the Electric Stimulation of Epidural Catheters in Term Pregnant Women

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