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The Response Patterns to the Electrical Stimulation of Epidural Catheters With Varying Pulse Widths in Term Pregnant Women

Primary Purpose

Labor Pain

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Nerve stimulator
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

16 Years - 55 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Women 16 years of age and older requesting an epidural for labour analgesia
  • Ability to communicate in English
  • Informed consent

Exclusion criteria:

  • Refusal to provide written informed consent
  • Inability to communicate in English
  • Abnormal vertebral anatomy, including but not limited to previous spine surgery and scoliosis
  • Allergy or hypersensitivity to lidocaine, bupivacaine or fentanyl
  • 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

0.1ms pulse width

1ms pulse width

Arm Description

The nerve stimulator will be connected to the epidural catheter through an adapter, which will be primed with a standard volume of 3 ml of sterile normal saline to allow for effective electrical conduction. The cathode terminal of the stimulator will then be attached to the metal hub of the adapter and the anode terminal will be connected to the electrode placed over the deltoid muscle. All patients will have the trans-catheter electric stimulation test (TCEST) performed with both a 1 ms pulse width and 0.1 ms pulse width and the order of administration will be randomized.

The nerve stimulator will be connected to the epidural catheter through an adapter, which will be primed with a standard volume of 3 ml of sterile normal saline to allow for effective electrical conduction. The cathode terminal of the stimulator will then be attached to the metal hub of the adapter and the anode terminal will be connected to the electrode placed over the deltoid muscle. All patients will have the trans-catheter electric stimulation test (TCEST) performed with both a 1 ms pulse width and 0.1 ms pulse width and the order of administration will be randomized.

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

Sensory level
The sensory level to ice at 20 minutes and 2 hours following injection of the standard epidural loading dose. The sensory level will be assessed from the sacral to the thoracic levels, bilaterally.
Motor block
Lower extremity motor block as assessed by the Bromage score (Range: 0-3) bilaterally at 20 minutes and 2 hours following the loading dose. 0 = No motor block (full flexion of knees and feet) = Partial motor block (just able to move knees and feet) = Almost complete motor block (able to move feet only) = Complete motor block (unable to move feet or knees)
Current (mA)
The current required to elicit a motor response on the initial TCEST and at 5 minutes after the test dose
Consumption of local anesthetic
Amount of local anesthetic consumed as measured on the pump in the first 2 hours.
Epidural block failure
Failure of the epidural analgesia, defined as no evidence of a sensory block to ice and absent pain relief in the first 20 minutes, OR the need for epidural catheter replacement within 2 hours of the loading dose.

Full Information

First Posted
May 2, 2016
Last Updated
July 31, 2017
Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02762149
Brief Title
The Response Patterns to the Electrical Stimulation of Epidural Catheters With Varying Pulse Widths in Term Pregnant Women
Official Title
The Response Patterns to the Electrical Stimulation of Epidural Catheters With Varying Pulse Widths in Term Pregnant Women
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Terminated
Why Stopped
Analysis after 20 patients was convincing for a negative result for the primary outcome, so the study was stopped.
Study Start Date
May 2016 (Actual)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (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
Epidural analgesia is commonly used for labor pain relief due to its safety and effectiveness. Despite a very high success rate, the epidural technique remains a somewhat blind technique and failures continue to occur. Unfortunately, there are no imaging techniques that can be used at the bedside to determine the proper positioning of the epidural catheter. The trans-catheter electric stimulation test (TCEST) has been successfully used for this purpose. This test is occasionally performed in situations where the immediate confirmation of the proper epidural catheter location is deemed necessary. The test helps to predict which epidurals might fail so that appropriate measures could be immediately implemented. There has been one duration of electrical stimulus (0.2 milliseconds) that has been used in the majority of studies and in clinical practice. With this duration of stimulation, the vast majority of cases show a unilateral motor response of the lower limbs during the TCEST. Studies on the stimulation of peripheral nerves (nerves in the arms and legs) have shown that an electrical stimulus with a longer duration is able to stimulate nerves which are farther away. Since nerves in the epidural space are similar in composition to peripheral nerves, the investigators expect to see a higher rate of bilateral response with the longer duration of stimulus. The investigators also hope to show that this bilateral response is predictive of a better functioning epidural. The investigators hypothesize that the incidence of a bilateral response to the TCEST will be higher with the 1.0 ms pulse width compared to 0.1 ms pulse width. Furthermore, the investigators hypothesize that a bilateral motor response associated with the 1.0 ms pulse width will be predictive of symmetry of sensory and motor block and of lower consumption of local anesthetic.
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 fellow or staff. Spinal ultrasound will be used prior to performing the epidural catheter insertion. The trans-catheter electric stimulation test (TCEST) will be performed at both a 0.1ms pulse width and a 1ms pulse width. The order in which the two pulse widths are applied will be randomly decided by computer. The test dose of local anesthetic will then be administered, and the TCEST will be repeated 5 minutes later. Again, both pulse widths (0.1ms, 1ms) will be used, and the order in which they are applied will be decided randomly. 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. The motor response pattern will be recorded for all TCESTs performed, and any relationship between pulse width and response pattern will be determined.

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
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.1ms pulse width
Arm Type
Active Comparator
Arm Description
The nerve stimulator will be connected to the epidural catheter through an adapter, which will be primed with a standard volume of 3 ml of sterile normal saline to allow for effective electrical conduction. The cathode terminal of the stimulator will then be attached to the metal hub of the adapter and the anode terminal will be connected to the electrode placed over the deltoid muscle. All patients will have the trans-catheter electric stimulation test (TCEST) performed with both a 1 ms pulse width and 0.1 ms pulse width and the order of administration will be randomized.
Arm Title
1ms pulse width
Arm Type
Active Comparator
Arm Description
The nerve stimulator will be connected to the epidural catheter through an adapter, which will be primed with a standard volume of 3 ml of sterile normal saline to allow for effective electrical conduction. The cathode terminal of the stimulator will then be attached to the metal hub of the adapter and the anode terminal will be connected to the electrode placed over the deltoid muscle. All patients will have the trans-catheter electric stimulation test (TCEST) performed with both a 1 ms pulse width and 0.1 ms pulse width and the order of administration will be randomized.
Intervention Type
Device
Intervention Name(s)
Nerve stimulator
Other Intervention Name(s)
Stimpod NMS 450
Intervention Description
The nerve stimulator (Stimpod NMS 450: Xavant technology (PTY) Ltd; Pretoria, South Africa or similar nerve stimulator) will be connected to the epidural catheter through an adapter (Johans ECG Adapter, Arrow International Inc., Reading). The epidural catheter and the adapter will be primed with a standard volume of 3 ml of sterile normal saline to allow for effective electrical conduction. Secured connections and avoidance of any air within in the system must be ensured to avoid high impedance in the circuit, which could result in false negatives. The cathode terminal of the stimulator will then be attached to the metal hub of the adapter and the anode terminal will be connected to the electrode placed over the deltoid muscle.
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
Sensory level
Description
The sensory level to ice at 20 minutes and 2 hours following injection of the standard epidural loading dose. The sensory level will be assessed from the sacral to the thoracic levels, bilaterally.
Time Frame
2 hours
Title
Motor block
Description
Lower extremity motor block as assessed by the Bromage score (Range: 0-3) bilaterally at 20 minutes and 2 hours following the loading dose. 0 = No motor block (full flexion of knees and feet) = Partial motor block (just able to move knees and feet) = Almost complete motor block (able to move feet only) = Complete motor block (unable to move feet or knees)
Time Frame
2 hours
Title
Current (mA)
Description
The current required to elicit a motor response on the initial TCEST and at 5 minutes after the test dose
Time Frame
5 minutes
Title
Consumption of local anesthetic
Description
Amount of local anesthetic consumed as measured on the pump in the first 2 hours.
Time Frame
2 hours
Title
Epidural block failure
Description
Failure of the epidural analgesia, defined as no evidence of a sensory block to ice and absent pain relief in the first 20 minutes, OR the need for epidural catheter replacement within 2 hours of the loading dose.
Time Frame
2 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women 16 years of age and older requesting an epidural for labour analgesia Ability to communicate in English Informed consent Exclusion criteria: Refusal to provide written informed consent Inability to communicate in English Abnormal vertebral anatomy, including but not limited to previous spine surgery and scoliosis Allergy or hypersensitivity to lidocaine, bupivacaine or fentanyl 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

Plan to Share IPD
No
Citations:
PubMed Identifier
28936608
Citation
Zakus P, Bittencourt R, Downey K, Tsui BCH, Carvalho JCA. The effect of an increased pulse width on the pattern of motor response (unilateral versus bilateral) during the Tsui test in labouring parturients: a randomized crossover trial. Can J Anaesth. 2017 Dec;64(12):1211-1217. doi: 10.1007/s12630-017-0977-y. Epub 2017 Sep 21.
Results Reference
derived

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The Response Patterns to the Electrical Stimulation of Epidural Catheters With Varying Pulse Widths in Term Pregnant Women

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