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

NCT02479763 | Completed Phase 2 Results DMC

• 1 other identifier: 15-077 MUHC
• Study Type: interventional
• Target: 106
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Anesthesia

Keywords

Epidural waveform analysis; Loss of resistance

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Conventional loss-of-resistance

NO INTERVENTION

Waveform-confirmed loss-of-resistance

EXPERIMENTAL

Procedure: Waveform-confirmed loss-of-resistance

Interventions

Waveform-confirmed loss-of-resistance PROCEDURE

Using waveform analysis to confirm thoracic epidural space

Waveform-confirmed loss-of-resistance

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montreal General Hospital: lead

Study Sites (2)

Montreal General Hospital, McGill University

Montreal, Quebec, H3G 1A4, Canada

Location

Ramathibodi Hospital, Mahidol University

Ratchathewi, Bangkok, 10400, Thailand

Location

Results Point of Contact

• Title: Dr. De QH Tran
• Organization: Montreal General Hospital

de_tran@hotmail.com

514-934-1934

Study Officials

• De QH Tran

  McGill University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: June 22, 2015
• First Posted: June 24, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 22, 2016
• Results First Posted: February 22, 2016

Record last verified: 2016-01

Locations

CA (1); TH (1)