A Comparison Between Conventional and Waveform-Confirmed Loss-of-Resistance for Thoracic Epidural Blocks

Anesthesia Clinical Trial

Official title:

A Randomized Comparison Between Conventional and Waveform-Confirmed Loss-of-Resistance for Thoracic Epidural Blocks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02479763
• Other study ID #: 15-077 MUHC
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 22, 2015
• Last updated: January 23, 2016
• Start date: June 2015
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Montreal General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

In the investigators' institution, the failure rate for thoracic epidural blocks is 23.1%. This stems from the prevalence of trainee operators coupled with the non-specific nature of loss-of-resistance. In the current randomized trial, we will set out to compare conventional and epidural waveform analysis-confirmed loss-of-resistance. The investigators' research hypothesis is that loss-of-resistance combined with epidural waveform analysis will decrease the failure rate of thoracic epidural blocks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• the patients undergoing thoracic epidural catheter insertion for thoracic and abdominal surgery or rib fractures with American Society of Anesthesiologists (ASA) classification 1-3 and body mass index between 18 and 35

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, or International Normalized Ratio = 1.4)

• 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 (LA)

• pregnancy

• prior surgery in the thoracic spine

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia

Intervention

Procedure:
• Waveform-confirmed loss-of-resistance
Using waveform analysis to confirm thoracic epidural space

Locations

Country	Name	City	State
Canada	Montreal General Hospital, McGill University	Montreal	Quebec
Thailand	Ramathibodi Hospital, Mahidol University	Ratchathewi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Montreal General Hospital

Countries where clinical trial is conducted

Canada,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients With Successful Epidural Blocks	Fifteen minutes after the LA injection, a blinded observer will apply ice to the T1-L4 dermatomes and assess the epidural block. The criterion standard for success will be the presence of an epidural block (defined as a block to ice in at least 2 dermatomes bilaterally). If the operators cannot thread the catheter after 2 attempts, epidural blocks will considered failures.	up to 15 minutes after the procedure	No