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

NCT02762149 | Terminated

• 1 other identifier: 16-04
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Pain

Keywords

Tsui Test; Labour; Epidural catheter

Outcome Measures

Primary Outcomes (1)

• Motor response pattern

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

  5 minutes

Secondary Outcomes (5)

• Sensory level

  2 hours

• Motor block

  2 hours

• Current (mA)

  5 minutes

• Consumption of local anesthetic

  2 hours

• Epidural block failure

  2 hours

Study Arms (2)

0.1ms pulse width

ACTIVE COMPARATOR

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.

Device: Nerve stimulator

1ms pulse width

ACTIVE COMPARATOR

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.

Device: Nerve stimulator

Interventions

Nerve stimulator DEVICE

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.

Also known as: Stimpod NMS 450

0.1ms pulse width; 1ms pulse width

Eligibility Criteria

• Age: 16 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

Related Publications (1)

• 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.

  PMID: 28936608 DERIVED

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jose Carvalho, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2016
• First Posted: May 4, 2016
• Study Start: May 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 1, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)