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

NCT02762149 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-08-01

No results posted yet for this study

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.

Conditions

  • Labor Pain

Interventions

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.

Sponsors & Collaborators

  • Samuel Lunenfeld Research Institute, Mount Sinai Hospital

    lead OTHER

Principal Investigators

  • Jose Carvalho, MD · MOUNT SINAI HOSPITAL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02762149 on ClinicalTrials.gov