Epidural Waveform Analysis for Thoracic Epidural Blocks
NCT ID: NCT03603574
Last Updated: 2019-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2018-07-30
2019-02-02
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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EWA through the needle
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.
EWA through the needle
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 catheter
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.
EWA through the catheter
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).
Interventions
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EWA through the needle
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 catheter
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).
Eligibility Criteria
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Inclusion Criteria
* American Society of Anesthesiologists classification 1-3
* body mass index between 20 and 35
Exclusion Criteria
* coagulopathy
* renal failure
* hepatic failure
* allergy to local anesthetic
* pregnancy
* prior surgery in the thoracic spine
18 Years
80 Years
ALL
Yes
Sponsors
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Ramathibodi Hospital
OTHER
University of Chile
OTHER
McGill University Health Centre/Research Institute of the McGill University Health Centre
OTHER
Responsible Party
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De Tran
Professor
Principal Investigators
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De Q Tran, MD, FRCPC
Role: PRINCIPAL_INVESTIGATOR
McGill University Health Centre/Research Institute of the McGill University Health Centre
Locations
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Hospital Clínico Universidad de Chile
Santiago, RM, Chile
Ramathibodi Hospital
Bangkok, , Thailand
Countries
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References
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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.
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.
BONICA J. Continuous peridural block. Anesthesiology. 1956 Jul-Aug;17(4):626-30. No abstract available.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2019-4669
Identifier Type: -
Identifier Source: org_study_id
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