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

Labor Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02762149
• Other study ID #: 16-04
• Status: Terminated
• Phase: N/A
• First received: May 2, 2016
• Last updated: July 31, 2017
• Start date: May 2016
• Est. completion date: August 2016

Study information

• Verified date: July 2017
• Source: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Labor Pain

Intervention

Device:
• Nerve stimulator
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.

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motor response pattern	Motor response pattern to the electrical stimulation of the epidural catheter, either unilateral or bilateral.	5 minutes
Secondary	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.	2 hours
Secondary	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)	2 hours
Secondary	Current (mA)	The current required to elicit a motor response on the initial TCEST and at 5 minutes after the test dose	5 minutes
Secondary	Consumption of local anesthetic	Amount of local anesthetic consumed as measured on the pump in the first 2 hours.	2 hours
Secondary	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.	2 hours