Analgesia, EpiduralNCT02785055
Neuraxial Ultrasound for Thoracic Epidural Placement
A study testing Thoracic Epidural Placement, Bupivacaine 0.05% and Hydromorphone 0.01mg/mL in people with Analgesia, Epidural, run by Benaroya Research Institute at 1 site in United States.
Trial summary
This blinded, randomized study compares standard palpation to ultrasound-assisted landmark identification of the thoracic spine for thoracic epidural catheterization. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Analgesia, Epidural
- What is being tested?
- Thoracic Epidural Placement, Bupivacaine 0.05% and Hydromorphone 0.01mg/mL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Feb 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiology Classification I-IV
- thoracic surgery
- abdominal surgery
Who cannot join
- contraindications to epidural catheter
- pregnancy
- coagulopathy
- infection (localized)
- allergy to local anesthetics
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Mason Medical Center
Seattle, Washington, 98101
About this study
Official title: Evaluation of Ultrasound-Assisted Thoracic Epidural Placement in Patients Undergoing Upper Abdominal and Thoracic Surgery: A Randomized, Double-Blind Study
This blinded, randomized study compares standard palpation to ultrasound-assisted landmark identification of the thoracic spine for thoracic epidural catheterization.
Read the detailed description
In this study, the investigators will utilize ultrasonography to identify midline bony landmarks including spinous processes, laminae, and intervertebral interspaces prior to the initial needle placement and compare this to standard palpation of the bony thoracic spine for thoracic epidural placement. The investigators will evaluate and compare the two needle localization techniques by the following outcomes: time to identify the epidural space by loss of resistance, needle passes, skin punctures, recovery room pain scores, and epidural success.
- Conditions
- Analgesia, Epidural
- Being tested
- Thoracic Epidural Placement, Bupivacaine 0.05%, Hydromorphone 0.01mg/mL
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic Epidural PlacementProcedure or surgery
Thoracic Epidural Placement
Bupivacaine 0.05%Drug
Delivery of epidural solution containing both bupivacaine 0.05%/hydromorphone0.01mg/mL solution
Hydromorphone 0.01mg/mLDrug
Delivery of epidural solution containing both bupivacaine 0.05%/hydromorphone0.01mg/mL solution
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-Assisted | Active comparator | Ultrasound assisted marking of the thoracic spine on the skin for Thoracic Epidural Placement Receives: Procedure: Thoracic Epidural Placement; Drug: Bupivacaine 0.05%; Drug: Hydromorphone 0.01mg/mL |
| Palpation | Active comparator | Palpation marking of the thoracic spine on the skin for Thoracic Epidural Placement Receives: Procedure: Thoracic Epidural Placement; Drug: Bupivacaine 0.05%; Drug: Hydromorphone 0.01mg/mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to epidural space identification
Needle insertion through the skin until loss-of-resistance with slip syringe, evaluated by a blinded individual reviewing a video recording of the procedure.
Measured: Estimated 10 minutes
Secondary outcomes (4)
Needle passes
Attempt to place needle into the interlaminar foramina. Needle tip movements toward midline and cephalad were counted as s single pass. Additional passes were counted when the needle was returned to a plane parallel to the skin.
Measured: Estimated 10 minutes
Needle skin punctures
Complete needle withdrawal from the skin and re-insertion at new location
Measured: Estimated 10 minutes
Pain Score
Numeric rating scale pain score on recovery room arrival, prior to IV analgesics.
Measured: Through study completion, estimated 4 hours
Working epidural
Loss of temperature discrimination to ice and pain score <= 5.
Measured: Through study completion, estimated 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study startApr 2009
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Analgesia, EpiduralStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benaroya Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Auyong, Benaroya Research Institute
- Investigators
- David Auyong, MD, Principal investigator, Virginia Mason Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02785055
- Sponsor's protocol ID
- IRB08130
- Status last verified
- May 2016
- First submitted
- 18 May 2016
- Last updated
- 27 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: No Plan in place
Publications
Auyong DB, Hostetter L, Yuan SC, Slee AE, Hanson NA. Evaluation of Ultrasound-Assisted Thoracic Epidural Placement in Patients Undergoing Upper Abdominal and Thoracic Surgery: A Randomized, Double-Blind Study. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):204-209. doi: 10.1097/AAP.0000000000000540.
PubMed 28002229
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ultrasound-Assisted Thoracic Epidural Placement in Patients Undergoing Upper Abdominal and Thoracic Surgery: A Randomized, Double-Blind Study
- ClinicalTrials.gov ID
- NCT02785055
- Acronym / sponsor ID
- IRB08130
- Conditions
- Analgesia, Epidural
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Benaroya Research InstituteUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 27 May 2016 (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.
This blinded, randomized study compares standard palpation to ultrasound-assisted landmark identification of the thoracic spine for thoracic epidural catheterization.
Detailed description
In this study, the investigators will utilize ultrasonography to identify midline bony landmarks including spinous processes, laminae, and intervertebral interspaces prior to the initial needle placement and compare this to standard palpation of the bony thoracic spine for thoracic epidural placement. The investigators will evaluate and compare the two needle localization techniques by the following outcomes: time to identify the epidural space by loss of resistance, needle passes, skin punctures, recovery room pain scores, and epidural success.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-Assisted | Active comparator | Procedure: Thoracic Epidural Placement, Drug: Bupivacaine 0.05%, Drug: Hydromorphone 0.01mg/mLUltrasound assisted marking of the thoracic spine on the skin for Thoracic Epidural Placement |
| Palpation | Active comparator | Procedure: Thoracic Epidural Placement, Drug: Bupivacaine 0.05%, Drug: Hydromorphone 0.01mg/mLPalpation marking of the thoracic spine on the skin for Thoracic Epidural Placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiology Classification I-IV
- thoracic surgery
- abdominal surgery
Key exclusion criteria (5 listed)
- contraindications to epidural catheter
- pregnancy
- coagulopathy
- infection (localized)
- allergy to local anesthetics
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 |
|---|---|---|
| Thoracic Epidural PlacementThoracic Epidural Placement | Procedure or surgery | Palpation, Ultrasound-Assisted |
| Bupivacaine 0.05%Delivery of epidural solution containing both bupivacaine 0.05%/hydromorphone0.01mg/mL solution | Drug | Palpation, Ultrasound-Assisted |
| Hydromorphone 0.01mg/mLDelivery of epidural solution containing both bupivacaine 0.05%/hydromorphone0.01mg/mL solution | Drug | Palpation, Ultrasound-Assisted |
Primary outcome
Time to epidural space identification
Time frame: Estimated 10 minutes
Needle insertion through the skin until loss-of-resistance with slip syringe, evaluated by a blinded individual reviewing a video recording of the procedure.
4 secondary outcomes
Needle passes
Time frame: Estimated 10 minutes
Needle skin punctures
Time frame: Estimated 10 minutes
Pain Score
Time frame: Through study completion, estimated 4 hours
Working epidural
Time frame: Through study completion, estimated 4 hours
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 27 May 2016.
- Derived from this study: PubMed 28002229Auyong DB, Hostetter L, Yuan SC, Slee AE, Hanson NA. Evaluation of Ultrasound-Assisted Thoracic Epidural Placement in Patients Undergoing Upper Abdominal and Thoracic Surgery: A Randomized, Double-Blind Study. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):204-209. doi: 10.1097/AAP.0000000000000540.
- Individual participant dataSharing planned: Undecided. No Plan in place
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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.
David Auyong, MD principal investigator
Virginia Mason Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic Epidural Placement, Bupivacaine 0.05% and Hydromorphone 0.01mg/mL in people with Analgesia, Epidural, run by Benaroya Research Institute at 1 site in United States.
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 27 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 1 site in United States. 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?
Time to epidural space identification (time frame: Estimated 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02785055, which also lists 1 linked publication.
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 27 May 2016.