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

31. juli 2017 oppdatert av: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

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.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

20

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G1X5
        • Mount Sinai Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

16 år til 55 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 0.1ms pulse width
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.
Enhet: 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.
Andre navn:
  • Stimpod NMS 450
Aktiv komparator: 1ms pulse width
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.
Enhet: 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.
Andre navn:
  • Stimpod NMS 450

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Motor response pattern
Tidsramme: 5 minutes
Motor response pattern to the electrical stimulation of the epidural catheter, either unilateral or bilateral.
5 minutes

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Sensory level
Tidsramme: 2 hours
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
Motor block
Tidsramme: 2 hours

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)

  1. = Partial motor block (just able to move knees and feet)
  2. = Almost complete motor block (able to move feet only)
  3. = Complete motor block (unable to move feet or knees)
2 hours
Current (mA)
Tidsramme: 5 minutes
The current required to elicit a motor response on the initial TCEST and at 5 minutes after the test dose
5 minutes
Consumption of local anesthetic
Tidsramme: 2 hours
Amount of local anesthetic consumed as measured on the pump in the first 2 hours.
2 hours
Epidural block failure
Tidsramme: 2 hours
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mai 2016

Primær fullføring (Faktiske)

1. august 2016

Studiet fullført (Faktiske)

1. august 2016

Datoer for studieregistrering

Først innsendt

2. mai 2016

Først innsendt som oppfylte QC-kriteriene

3. mai 2016

Først lagt ut (Anslag)

4. mai 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. august 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

31. juli 2017

Sist bekreftet

1. juli 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 16-04

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

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