Clinical trial NCT03603574: Epidural Waveform Analysis for Thoracic Epidural Blocks
Official title: A Randomized Comparison Between Epidural Waveform Analysis Through the Needle Versus the Catheter for Thoracic Epidural Blocks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Procedure, Unspecified
Keywords: Abdomen/surgery
Thoracic Surgery
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Ramathibodi Hospital
name: University of Chile
First posted: 2018-07-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized trial
Primary purpose: OTHER

Brief summary: Epidural waveform analysis (EWA) provides a simple confirmatory adjunct for loss-of-resistance (LOR): when the needle/catheter tip is correctly positioned inside the epidural space, pressure measurement results in a pulsatile waveform. Epidural waveform analysis can be carried out through the tip of the needle or the catheter. In this randomized trial, the objective is to compare epidural waveform analysis through the needle (EWA-N) and through the catheter (EWA-C) for thoracic epidural blocks.

Detailed description: The epidural space is most commonly identified with loss-of-resistance (LOR). Though sensitive Epidural waveform analysis (EWA) provides a simple confirmatory adjunct for LOR. When the needle (or catheter) is correctly positioned inside the epidural space, pressure measurement at its tip results in a pulsatile waveform synchronized with arterial pulsations Currently, there exist two different methods for EWA. Since local anesthetic (LA) is administered through the catheter, pressure transduction through its tip ensures that it is properly positioned inside the epidural space prior to LA injection. Alternately, EWA can be performed through the needle prior to blind advancement of the epidural catheter.

Thus, in this randomized trial, the aim is to compare epidural waveform analysis through the needle (EWA-N) and through the catheter (EWA-C) for thoracic epidural blocks. The hypothesis is that, compared to EWA-C, EWA-N will result in a shorter performance time.

Eligibility criteria: Inclusion Criteria:

* age between 18 and 80 years
* American Society of Anesthesiologists classification 1-3
* body mass index between 20 and 35

Exclusion Criteria:

* adults who are unable to give their own consent
* coagulopathy
* renal failure
* hepatic failure
* allergy to local anesthetic
* pregnancy
* prior surgery in the thoracic spine

Primary outcomes:
measure: Performance time of block
timeFrame: From skin infiltration until local anesthetic administration through the needle or catheter, up to 60 minutes
Secondary outcomes:
measure: Incidence of successful epidural block
timeFrame: 15 minutes after the administration of local anesthetic through the epidural catheter
measure: Procedural pain during epidural block assessed by the numeric rating scale
timeFrame: From the performance of the epidural block until induction of general anesthesia, up to 2 hours
measure: Postoperative pain related to surgical incision assessed by the numeric rating scale
timeFrame: twice a day from the arrival at PACU or until catheter removal, up to 5 days
measure: Local anesthetic consumption
timeFrame: once a day from the arrival at PACU or until catheter removal, up to 5 days
measure: Breakthrough opioid consumption (if required)
timeFrame: once a day from the arrival at PACU or until catheter removal, up to 5 days
measure: Incidence of adverse events
timeFrame: Once a day from catheter insertion until removal, up to 5 days
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Clínico Universidad de Chile
state: RM
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: De Q Tran, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Leurcharusmee P, Arnuntasupakul V, Chora De La Garza D, Vijitpavan A, Ah-Kye S, Saelao A, Tiyaprasertkul W, Finlayson RJ, Tran DQ. Reliability of Waveform Analysis as an Adjunct to Loss of Resistance for Thoracic Epidural Blocks. Reg Anesth Pain Med. 2015 Nov-Dec;40(6):694-7. doi: 10.1097/AAP.0000000000000313.
citation: Tran DQ, Van Zundert TC, Aliste J, Engsusophon P, Finlayson RJ. Primary Failure of Thoracic Epidural Analgesia in Training Centers: The Invisible Elephant? Reg Anesth Pain Med. 2016 May-Jun;41(3):309-13. doi: 10.1097/AAP.0000000000000394.
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citation: Tangjitbampenbun A, Layera S, Arnuntasupakul V, Apinyachon W, Venegas K, Godoy J, Aliste J, Bravo D, Blanch A, Webar J, Saadawi M, Owen A, Finlayson RJ, Tran DQ. Randomized comparison between epidural waveform analysis through the needle versus the catheter for thoracic epidural blocks. Reg Anesth Pain Med. 2019 May 14:rapm-2019-100478. doi: 10.1136/rapm-2019-100478. Online ahead of print.