Epidural Waveform Analysis for Thoracic Epidural Blocks

Surgical Procedure, Unspecified Clinical Trial

Official title:

A Randomized Comparison Between Epidural Waveform Analysis Through the Needle Versus the Catheter for Thoracic Epidural Blocks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03603574
• Other study ID #: 2019-4669
• Status: Completed
• Phase: N/A
• Start date: July 30, 2018
• Est. completion date: February 2, 2019

Study information

• Verified date: February 2019
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 2, 2019
• Est. primary completion date: January 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Surgical Procedure, Unspecified

Intervention

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.
• 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).

Locations

Country	Name	City	State
Chile	Hospital Clínico Universidad de Chile	Santiago	RM
Thailand	Ramathibodi Hospital	Bangkok

Sponsors (3)

Lead Sponsor	Collaborator
McGill University Health Center	Hospital Clínico Universidad de Chile, Ramathibodi Hospital

Countries where clinical trial is conducted

Chile,  Thailand, 

References & Publications (12)

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. — View Citation

BONICA J. Continuous peridural block. Anesthesiology. 1956 Jul-Aug;17(4):626-30. — View Citation

Chayen D, Nathan H, Chayen M. The psoas compartment block. Anesthesiology. 1976 Jul;45(1):95-9. — View Citation

de Médicis E, Pelletier J, Martin R, Loignon MJ, Tétrault JP, Laroche L. Technical report: optimal quantity of saline for epidural pressure waveform analysis. Can J Anaesth. 2007 Oct;54(10):818-21. — View Citation

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):1830-3. — View Citation

Eason MJ, Wyatt R. Paravertebral thoracic block-a reappraisal. Anaesthesia. 1979 Jul-Aug;34(7):638-42. — View 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. — View Citation

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. — View Citation

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):1178-80, table of contents. — View Citation

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. — View Citation

Tran DQ, González 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. Review. — View 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of successful epidural block	bilateral block to ice in at least 2 dermatomes	15 minutes after the administration of local anesthetic through the epidural catheter
Secondary	Procedural pain during epidural block assessed by the numeric rating scale	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)	From the performance of the epidural block until induction of general anesthesia, up to 2 hours
Secondary	Postoperative pain related to surgical incision assessed by the numeric rating scale	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)	twice a day from the arrival at PACU or until catheter removal, up to 5 days
Secondary	Local anesthetic consumption	amount of local anesthetic consumed	once a day from the arrival at PACU or until catheter removal, up to 5 days
Secondary	Breakthrough opioid consumption (if required)	amount of opioids consumed	once a day from the arrival at PACU or until catheter removal, up to 5 days
Secondary	Incidence of adverse events	side effects related to the performance of the epidural block (eg, dural/vascular puncture, paresthesia) or breakthrough opioids (nausea, vomiting, pruritus, somnolence, respiratory depression)	Once a day from catheter insertion until removal, up to 5 days