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.

Study Overview

• Status: Completed
• Conditions: Pregnancy
• Intervention / Treatment: Other: Obstetrical patients

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • Royal Victoria Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Obstetrical patients; Obstetrical patients requiring epidural analgesia for delivery	Other: Obstetrical patients; Epidural waveform analysis as a confirmation of loss of Resistance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate	Success rate evaluated with sensory block to ice	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epidural waveform analysis	presence or absence of an epidural waveform measured through the epidural catheter right after insertion	Immediately after epidural catheter insertion

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Investigators: Principal Investigator: Albert Moore, MD, FRCPC, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: May 26, 2016
• First Submitted That Met QC Criteria: June 2, 2016
• First Posted (Estimate): June 8, 2016

Study Record Updates

• Last Update Posted (Actual): March 20, 2017
• Last Update Submitted That Met QC Criteria: March 17, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: MUHC-JGH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO