PainNCT01449214
Ultrasound-Guided Technique for Thoracic Epidural Insertion
A study testing Ultrasound and Landmarking in people with Pain, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Ultrasound and Landmarking
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesCanada
- Study dates
- Oct 2011to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years old.
- Elective major abdominal or thoracic surgery requiring thoracic epidural anesthesia/analgesia.
- Consent to participate and signed consent form.
Who cannot join
- Contraindication to epidural anesthesia.
- Marked spinal deformities or a history of spinal instrumentation
- Emergency surgery.
- Inability to communicate in English.
- BMI>35 kgm-2
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
University Health Network - Toronto General Hospital
Toronto, Ontario, M5G 2C4
Mount Sinai Hospital
Toronto, Ontario, M5G1X5
About this study
Official title: Ultrasound-Guided Technique for Thoracic Epidural Insertion: A Randomized Controlled Trial
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
Read the 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
- Conditions
- Pain
- Being tested
- Ultrasound, Landmarking
- Keywords
- Thoracic epidural, Epidural anesthesia, Ultrasound, Palpation, Thoracic spine
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundProcedure or surgery
Ultrasound-guided technique
LandmarkingProcedure or surgery
Landmark-guided technique
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound | Experimental | Use of ultrasound to identify interlaminar spaces for needle insertion. Intervention/Procedure: ultrasound-guided technique. Receives: Procedure: Ultrasound |
| Landmarking | Active comparator | Use of manual palpation to identify anatomic landmarks for needle insertion. Procedure/Intervention: landmark-guided technique. Receives: Procedure: Landmarking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 30 minutes
Secondary outcomes (6)
Bony contacts
number of bony contacts during the needle insertion
Measured: 30 minutes
New insertion point
need to re-insert the epidural needle in the same interlaminar space, but using different insertion point
Measured: 30 minutes
Number of insertions
number of different interlaminar space insertions
Measured: 30 minutes
duration of ultrasound scanning
duration of ultrasound scanning
Measured: 30 minutes
duration of epidural procedure
duration of epidural procedure
Measured: 30 minutes
complications during epidural insertion
complications during epidural insertion
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cristian Arzola, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01449214
- Sponsor's protocol ID
- 11-03
- Status last verified
- Apr 2016
- First submitted
- 6 Oct 2011
- Last updated
- 2 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Technique for Thoracic Epidural Insertion: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01449214
- Acronym / sponsor ID
- 11-03
- Conditions
- Pain
- Keywords
- Thoracic epidural, Epidural anesthesia, Ultrasound, Palpation, Thoracic spine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 10 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound | Experimental | Procedure: UltrasoundUse of ultrasound to identify interlaminar spaces for needle insertion. Intervention/Procedure: ultrasound-guided technique. |
| Landmarking | Active comparator | Procedure: LandmarkingUse of manual palpation to identify anatomic landmarks for needle insertion. Procedure/Intervention: landmark-guided technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years old.
- Elective major abdominal or thoracic surgery requiring thoracic epidural anesthesia/analgesia.
- Consent to participate and signed consent form.
Key exclusion criteria (5 listed)
- Contraindication to epidural anesthesia.
- Marked spinal deformities or a history of spinal instrumentation
- Emergency surgery.
- Inability to communicate in English.
- BMI>35 kgm-2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundUltrasound-guided technique | Procedure or surgery | Ultrasound |
| LandmarkingLandmark-guided technique | Procedure or surgery | Landmarking |
Primary outcome
Needle redirections
Time frame: 30 minutes
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)
6 secondary outcomes
Bony contacts
Time frame: 30 minutes
New insertion point
Time frame: 30 minutes
Number of insertions
Time frame: 30 minutes
duration of ultrasound scanning
Time frame: 30 minutes
duration of epidural procedure
Time frame: 30 minutes
complications during epidural insertion
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristian Arzola, MD principal investigator
MOUNT SINAI HOSPITAL
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound and Landmarking in people with Pain, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Needle redirections (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2016.