NCT01449214

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable pain

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 10, 2011

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 2, 2016

Status Verified

April 1, 2016

Enrollment Period

4.2 years

First QC Date

October 6, 2011

Last Update Submit

April 29, 2016

Conditions

Pain

Keywords

Thoracic epiduralEpidural anesthesiaUltrasoundPalpationThoracic spine

Outcome Measures

Primary Outcomes (1)

  • Needle redirections

    Number 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)

    30 minutes

Secondary Outcomes (6)

  • Bony contacts

    30 minutes

  • New insertion point

    30 minutes

  • Number of insertions

    30 minutes

  • duration of ultrasound scanning

    30 minutes

  • duration of epidural procedure

    30 minutes

  • +1 more secondary outcomes

Study Arms (2)

Ultrasound

EXPERIMENTAL

Use of ultrasound to identify interlaminar spaces for needle insertion. Intervention/Procedure: ultrasound-guided technique.

Procedure: Ultrasound

Landmarking

ACTIVE COMPARATOR

Use of manual palpation to identify anatomic landmarks for needle insertion. Procedure/Intervention: landmark-guided technique.

Procedure: Landmarking

Interventions

UltrasoundPROCEDURE

Ultrasound-guided technique

Ultrasound
LandmarkingPROCEDURE

Landmark-guided technique

Landmarking

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Health Network - Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

MeSH Terms

Conditions

Pain

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Cristian Arzola, MD

    MOUNT SINAI HOSPITAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2011

First Posted

October 10, 2011

Study Start

October 1, 2011

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

May 2, 2016

Record last verified: 2016-04

Locations

CA(2)