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Ultrasound-Guided Technique for Thoracic Epidural Insertion

Ultrasound-Guided Technique for Thoracic Epidural Insertion: A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01449214
Enrollment
60
Registered
2011-10-10
Start date
2011-10-31
Completion date
2015-12-31
Last updated
2016-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Thoracic epidural, Epidural anesthesia, Ultrasound, Palpation, Thoracic spine

Brief summary

Thoracic epidural analgesia and anesthesia are effective in improving the quality of intraoperative and postoperative pain relief during thoracic and abdominal surgical procedures. Conventional epidural techniques have significant limitations. Due to the anatomic characteristics of the thoracic versus the lumbar intervertebral spaces, the insertion requires a more technically challenging paramedian approach. The safety and feasibility of bedside ultrasonography for the lumbar spine has already been established and it proves to be a valuable tool for neuraxial anesthesia in obstetric anesthesia

Detailed description

• The feasibility and the reliability of US imaging for the thoracic spine has been proven by comparing the findings of ultrasound scans to MRI measurements, which is the standard imaging technique for the depiction of the spine. Pre-puncture US assessment may contribute to the safety and efficacy of the thoracic epidural technique. The purpose of this study is to compare the ultrasound-guided thoracic epidural insertion technique with the conventional anatomic landmarking technique of contacting bone and walking-off the lamina

Interventions

PROCEDUREUltrasound

Ultrasound-guided technique

PROCEDURELandmarking

Landmark-guided technique

Sponsors

Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age \> 18 years old. * Elective major abdominal or thoracic surgery requiring thoracic epidural anesthesia/analgesia. * Consent to participate and signed consent form.

Exclusion criteria

* Contraindication to epidural anesthesia. * Marked spinal deformities or a history of spinal instrumentation * Emergency surgery. * Inability to communicate in English. * BMI\>35 kgm-2

Design outcomes

Primary

MeasureTime frameDescription
Needle redirections30 minutesNumber of needle redirections defined as the need to withdraw the epidural needle for the purpose of continuing on a different angle (sagittal or axial plane)

Secondary

MeasureTime frameDescription
New insertion point30 minutesneed to re-insert the epidural needle in the same interlaminar space, but using different insertion point
Number of insertions30 minutesnumber of different interlaminar space insertions
Bony contacts30 minutesnumber of bony contacts during the needle insertion
duration of epidural procedure30 minutesduration of epidural procedure
complications during epidural insertion30 minutescomplications during epidural insertion
duration of ultrasound scanning30 minutesduration of ultrasound scanning

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026