Epidural Waveform Analysis for Thoracic Epidural Blocks

NCT03603574 | Completed

• 1 other identifier: 2019-4669
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 2

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.

Conditions

Surgical Procedure, Unspecified

Keywords

Abdomen/surgery; Thoracic Surgery

Outcome Measures

Primary Outcomes (1)

• Performance time of block

  temporal interval in minutes between skin infiltration and local anesthetic administration through the epidural catheter (after obtaining a satisfactory waveform either through the needle or through the catheter depending on randomized group assignment).

  From skin infiltration until local anesthetic administration through the needle or catheter, up to 60 minutes

Secondary Outcomes (6)

• Incidence of successful epidural block

  15 minutes after the administration of local anesthetic through the epidural catheter

• Procedural pain during epidural block assessed by the numeric rating scale

  From the performance of the epidural block until induction of general anesthesia, up to 2 hours

• Postoperative pain related to surgical incision assessed by the numeric rating scale

  twice a day from the arrival at PACU or until catheter removal, up to 5 days

• Local anesthetic consumption

  once a day from the arrival at PACU or until catheter removal, up to 5 days

• Breakthrough opioid consumption (if required)

  once a day from the arrival at PACU or until catheter removal, up to 5 days

Study Arms (2)

EWA through the needle

EXPERIMENTAL

EWA through the needle group, 5 mL of normal saline are injected through the epidural needle after the occurrence of LOR. The needle is subsequently connected to the pressure transducer (leveled with the heart) via the sterile, rigid extension tubing. A satisfactory endpoint is defined as the presence of waveforms synchronized with arterial pulsations.

Device: EWA through the needle

EWA through the catheter

EXPERIMENTAL

EWA through the catheter group, the epidural catheter is advanced 5 cm beyond the needle tip after the occurrence of LOR. Subsequently, the operator injects 5 mL of normal saline through the catheter and the latter is connected to the pressure transducer via the sterile, rigid extension tubing. A satisfactory endpoint is defined as the presence of waveforms synchronized with arterial pulsations.

Device: EWA through the catheter

Interventions

EWA through the needle DEVICE

In the EWA-N group, 5 mL of normal saline are injected through the epidural needle after the occurrence of loss-of-resistance (LOR). The needle is connected to the pressure transducer. A satisfactory endpoint is defined as the presence of waveforms synchronized with arterial pulsations. In the absence of pulsatile waveforms, the operator injects an additional 2.5 mL-bolus of normal saline through the epidural needle and reconnects the latter to the pressure transducer. If no waveforms are detected after the second injection, the operator removes the needle and reattempts the epidural block at a different intervertebral level. A maximum of 3 levels is permitted: if waveforms are still absent at the third level, the operator simply accepts LOR as the technical endpoint.

EWA through the needle

EWA through the catheter DEVICE

In the EWA-C group, the epidural catheter is advanced 5 cm beyond the needle tip after the occurrence of LOR. Subsequently, the operator injects 5 mL of normal saline through the catheter and the latter is connected to the pressure transducer via the sterile, rigid extension tubing. A satisfactory endpoint is defined as the presence of waveforms. In the absence of pulsatile waveforms, the operator injects an additional 2.5 mL-bolus of saline through the catheter and reconnects the latter to the pressure transducer. If no waveforms are detected after the second injection are still absent at the third level, the operator simply accepts this position for catheter placement (intent-to-treat analysis).

EWA through the catheter

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Ramathibodi Hospital: collaborator
• University of Chile: collaborator

Study Sites (2)

Hospital Clínico Universidad de Chile

Santiago, RM, Chile

Location

Ramathibodi Hospital

Bangkok, Thailand

Location

Related Publications (13)

• Tran DQ, Gonzalez AP, Bernucci F, Finlayson RJ. Confirmation of loss-of-resistance for epidural analgesia. Reg Anesth Pain Med. 2015 Mar-Apr;40(2):166-73. doi: 10.1097/AAP.0000000000000217. No abstract available.

  PMID: 25642911 BACKGROUND

• Sharrock NE. Recordings of, and an anatomical explanation for, false positive loss of resistance during lumbar extradural analgesia. Br J Anaesth. 1979 Mar;51(3):253-8. doi: 10.1093/bja/51.3.253.

  PMID: 435350 BACKGROUND

• BONICA J. Continuous peridural block. Anesthesiology. 1956 Jul-Aug;17(4):626-30. No abstract available.

  PMID: 13327296 BACKGROUND

• Lirk P, Kolbitsch C, Putz G, Colvin J, Colvin HP, Lorenz I, Keller C, Kirchmair L, Rieder J, Moriggl B. Cervical and high thoracic ligamentum flavum frequently fails to fuse in the midline. Anesthesiology. 2003 Dec;99(6):1387-90. doi: 10.1097/00000542-200312000-00023.

  PMID: 14639154 BACKGROUND

• Lirk P, Moriggl B, Colvin J, Keller C, Kirchmair L, Rieder J, Kolbitsch C. The incidence of lumbar ligamentum flavum midline gaps. Anesth Analg. 2004 Apr;98(4):1178-1180. doi: 10.1213/01.ANE.0000101486.41355.35.

  PMID: 15041621 BACKGROUND

• Chayen D, Nathan H, Chayen M. The psoas compartment block. Anesthesiology. 1976 Jul;45(1):95-9. doi: 10.1097/00000542-197607000-00019. No abstract available.

  PMID: 937760 BACKGROUND

• Eason MJ, Wyatt R. Paravertebral thoracic block-a reappraisal. Anaesthesia. 1979 Jul-Aug;34(7):638-42. doi: 10.1111/j.1365-2044.1979.tb06363.x.

  PMID: 517716 BACKGROUND

• 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.

  PMID: 26469364 BACKGROUND

• 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.

  PMID: 27035462 BACKGROUND

• Arnuntasupakul V, Van Zundert TC, Vijitpavan A, Aliste J, Engsusophon P, Leurcharusmee P, Ah-Kye S, Finlayson RJ, Tran DQ. A Randomized Comparison Between Conventional and Waveform-Confirmed Loss of Resistance for Thoracic Epidural Blocks. Reg Anesth Pain Med. 2016 May-Jun;41(3):368-73. doi: 10.1097/AAP.0000000000000369.

  PMID: 26894628 BACKGROUND

• de Medicis E, Tetrault JP, Martin R, Robichaud R, Laroche L. A prospective comparative study of two indirect methods for confirming the localization of an epidural catheter for postoperative analgesia. Anesth Analg. 2005 Dec;101(6):1830-1833. doi: 10.1213/01.ANE.0000184130.73634.BE.

  PMID: 16301268 BACKGROUND

• de Medicis E, Pelletier J, Martin R, Loignon MJ, Tetrault JP, Laroche L. Technical report: optimal quantity of saline for epidural pressure waveform analysis. Can J Anaesth. 2007 Oct;54(10):818-21. doi: 10.1007/BF03021709.

  PMID: 17934163 BACKGROUND

• 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.

  PMID: 31092706 DERIVED

Study Officials

• De Q Tran, MD, FRCPC

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessment will not be present during the performance of the epidural block and waveform analysis.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized trial

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: July 27, 2018
• Study Start: July 30, 2018
• Primary Completion: January 30, 2019
• Study Completion: February 2, 2019
• Last Updated: February 6, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1); CL (1)