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Epidural Waveform Analysis for Thoracic Epidural Blocks

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03603574
Recruitment Status : Completed
First Posted : July 27, 2018
Last Update Posted : February 6, 2019
Sponsor:
Collaborators:
Ramathibodi Hospital
University of Chile
Information provided by (Responsible Party):
De Tran, McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

Condition or disease Intervention/treatment Phase
Surgical Procedure, Unspecified Device: EWA through the needle Device: EWA through the catheter Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized trial
Masking: Single (Outcomes Assessor)
Masking Description: The outcome assessment will not be present during the performance of the epidural block and waveform analysis.
Primary Purpose: Other
Official Title: A Randomized Comparison Between Epidural Waveform Analysis Through the Needle Versus the Catheter for Thoracic Epidural Blocks
Actual Study Start Date : July 30, 2018
Actual Primary Completion Date : January 30, 2019
Actual Study Completion Date : February 2, 2019

Arm Intervention/treatment
Experimental: 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.
Device: 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.

Experimental: 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.
Device: 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).




Primary Outcome Measures :
  1. Performance time of block [ Time Frame: From skin infiltration until local anesthetic administration through the needle or catheter, up to 60 minutes ]
    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).


Secondary Outcome Measures :
  1. Incidence of successful epidural block [ Time Frame: 15 minutes after the administration of local anesthetic through the epidural catheter ]
    bilateral block to ice in at least 2 dermatomes

  2. Procedural pain during epidural block assessed by the numeric rating scale [ Time Frame: From the performance of the epidural block until induction of general anesthesia, up to 2 hours ]
    pain in the back of the patient, related to the performance of the epidural block, using a numeric rating scale from 0 to 10 points (0=no pain and 10= worst imaginable pain)

  3. Postoperative pain related to surgical incision assessed by the numeric rating scale [ Time Frame: twice a day from the arrival at PACU or until catheter removal, up to 5 days ]
    pain at rest and upon deep breathing/coughing, measured using a numeric rating scale from 0 to 10 points ((0=no pain and 10= worst imaginable pain)

  4. Local anesthetic consumption [ Time Frame: once a day from the arrival at PACU or until catheter removal, up to 5 days ]
    amount of local anesthetic consumed

  5. Breakthrough opioid consumption (if required) [ Time Frame: once a day from the arrival at PACU or until catheter removal, up to 5 days ]
    amount of opioids consumed

  6. Incidence of adverse events [ Time Frame: Once a day from catheter insertion until removal, up to 5 days ]
    side effects related to the performance of the epidural block (eg, dural/vascular puncture, paresthesia) or breakthrough opioids (nausea, vomiting, pruritus, somnolence, respiratory depression)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03603574


Locations
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Chile
Hospital Clínico Universidad de Chile
Santiago, RM, Chile
Thailand
Ramathibodi Hospital
Bangkok, Thailand
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
Ramathibodi Hospital
University of Chile
Investigators
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Principal Investigator: De Q Tran, MD, FRCPC McGill University Health Centre/Research Institute of the McGill University Health Centre
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: De Tran, Professor, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT03603574    
Other Study ID Numbers: 2019-4669
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by De Tran, McGill University Health Centre/Research Institute of the McGill University Health Centre:
Abdomen/surgery
Thoracic Surgery