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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02793596
• Other study ID #: MUHC-JGH
• Status: Completed
• Phase: N/A
• First received: May 26, 2016
• Last updated: March 17, 2017
• Start date: August 2016

Study information

• Verified date: March 2017
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy

Intervention

Other:
• Obstetrical patients
Epidural waveform analysis as a confirmation of loss of Resistance

Locations

Country	Name	City	State
Canada	Royal Victoria Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Center

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate	Success rate evaluated with sensory block to ice	15 minutes
Secondary	Epidural waveform analysis	presence or absence of an epidural waveform measured through the epidural catheter right after insertion	Immediately after epidural catheter insertion