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Completed

NCT Number: NCT02793596

Reliability of Waveform Analysis as an Adjunct to Loss of Resistance for Obstetrical Epidural Blocks

In this study, we will set out to confirm the reliability of epidural waveform analysis (EWA) as an adjunct to loss of resistance for obstetrical epidural blocks.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Royal Victoria Hospital

Montreal, Quebec, H4A 3J1, Canada

About this study

After loss of resistance, 5 mL of normal saline will be injected through the epidural needle; the latter will then be connected to a pressure transducer (leveled with the heart) using a rigid tubing. A pressure recording of the epidural waveform will be saved for future assessment by a blinded observer.

After the recording of the waveform, the rigid tubing will be disconnected from the epidural needle. A 4 mL bolus of lidocaine 2% with epinephrine 5 µg/mL will be injected through the latter. An epidural catheter will be advanced 3-4 cm past the tip of the needle inside the epidural space. The needle will then be removed and the catheter secured to the skin in the usual fashion.

Fifteen minutes after the injection of the local anesthetic bolus, a blinded observer will apply ice to the T1-L5 dermatomes and assess the epidural block.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-American Society of Anesthesiologists classification 1-3

Exclusion criteria

  • adults who are unable to give their own consent
  • coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50)
  • renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie creatinine ≥ 100)
  • hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie transaminases ≥ 100)
  • allergy to local anesthetic
  • prior surgery in the lumbar spine

Treatment and study plan

Obstetrical patients

Other

Epidural waveform analysis as a confirmation of loss of Resistance

Primary outcomes

  1. Success rate

    Time frame: 15 minutes

    Success rate evaluated with sensory block to ice

Secondary outcomes

  1. Epidural waveform analysis

    Time frame: Immediately after epidural catheter insertion

    presence or absence of an epidural waveform measured through the epidural catheter right after insertion

Sponsors and collaborators

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
First posted
Jun 8, 2016
Registry last updated
Mar 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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