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

M

Montreal General Hospital

Status and phase

Completed
Phase 3
Phase 2

Conditions

Anesthesia

Treatments

Procedure: Waveform-confirmed loss-of-resistance

Study type

Interventional

Funder types

Other

Identifiers

NCT02479763
15-077 MUHC

Details and patient eligibility

About

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.

Enrollment

106 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

106 participants in 2 patient groups

Conventional loss-of-resistance
No Intervention group
Waveform-confirmed loss-of-resistance
Experimental group
Treatment:
Procedure: Waveform-confirmed loss-of-resistance

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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