SurgeryUSA-MAN-TENCT03559023
A Factorial Trial of Ultrasound and Manometry to Improve the Success of Thoracic Epidural Placement
A study testing Ultrasound Only, Manometry Only and Ultrasound Plus Manometry in people with Surgery, run by Oregon Health and Science University at 1 site in United States.
Trial summary
To investigate the use of ultrasound and manometry to increase the success rate of thoracic epidural placement. The use of ultrasound for lumbar epidural catheter placement is well established and is thought to assist in identifying an optimal skin entry point, depth to lamina and ligamentum flavum, and needle… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Surgery
- What is being tested?
- Ultrasound Only, Manometry Only and Ultrasound Plus Manometry
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2018to 30 Sep 2020
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Epidural indicated for a T4-T10 placement site
- American Society of Anesthesiologists (ASA) physical status I to IV
Who cannot join
- Non-English speaking subjects in situations when an interpreter or consent in their native language is not available.
- Pregnant women
- Decsionally impaired
- Prisoners
- Children
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
OHSU
Portland, Oregon, 97239
Ryan Ivie, MD, 503-494-7641, ivie@ohsu.edu
About this study
To investigate the use of ultrasound and manometry to increase the success rate of thoracic epidural placement. The use of ultrasound for lumbar epidural catheter placement is well established and is thought to assist in identifying an optimal skin entry point, depth to lamina and ligamentum flavum, and needle trajectory. The use of sterile manometry tubing to demonstrate a falling and oscillating fluid column has been described as a confirmatory test in the placement of lumbar epidurals. This study will determine if the efficacy of thoracic epidural placement is improved if placement is performed with the use of either US, or manometry, or both techniques combined, compared with a standard landmark-based placement technique alone.
Read the detailed description
In a variety of thoracic and abdominal surgeries, thoracic epidural placement is associated with better pain relief, less opioid consumption, a decrease in adverse perioperative cardiac events, and improved intestinal perfusion and motility. Unfortunately, epidural catheter placement is challenging and is not always successful. The epidural space in the thoracic region is especially difficult to access due to the steep and inferior angulation of most of the spinous processes.
The vast majority of thoracic epidurals are placed using a landmark-based technique (i.e. without ultrasound guidance or fluoroscopy). In addition, a "loss of resistance" technique is typically used to confirm the needle has entered the epidural space. With a paramedian technique, the thoracic spinous processes are palpated (if possible), the needle is advanced through the skin just lateral to the spinous processes until lamina is contacted. The needle is then redirected medially based on an estimate of the location of the midline at the interlaminar space. The needle is then "walked" cephalad or caudad to blindly search for the interlaminar space. The depth to the lamina and interlaminar space are not known which introduces additional uncertainty in the mind of the operator, who must proceed with caution so as to not advance the needle too far and puncture the dural sac. It is not surprising that the landmark approach is associated with a significant number of unsuccessful attempts, long procedure times, and ineffective catheters, with the percentage of failed thoracic epidurals reported as high as 32%. In one study, the failure rate confirmed by both epidural waveform analysis and a sensory test after local anesthetic injection, the primary failure rate was found to be 23%-24%. A higher number of procedural attempts can also lead to an increased risk for complications including paresthesia, epidural hematoma, and dural puncture headaches. The high failure rate of this procedure highlights the need for more studies on ways to improve the techniques for thoracic epidural access.
Ultrasound (US) has proven to be useful in the imaging of the spine, and has also helped improve our ability to access the lumbar epidural space. Ultrasound measurement of the epidural space depth before epidural catheter placement decreased the rate of lumbar epidural catheter replacements, and reduced the number of epidural attempts when performed by first year residents compared to attempts without ultrasound guidance. In another study the use of ultrasound to identify the depth and location of the interlaminar and epidural space improved placement of labor epidurals with a lower number of block failures, a higher number of complete blockade, a higher rate of subject satisfaction, and lower VAS scores. Ultrasound has also been used to image the thoracic spine and epidural space.
The superior medial border of the thoracic transverse process aligns with the interlaminar space. This anatomical fact, combined with the ability to use ultrasound to identify the thoracic transverse processes and other bony landmarks forms the basis of this study. In the transverse plane, ultrasound can be used to identify the thoracic spinous processes and the midline. In the paramedian plane, the lamina, articular process and transverse process can be identified. In the lumbar spine, once the articular process is identified, a paramedian angulation of the ultrasound beam is used to identify an "acoustic window" between the lamina and into the spinal canal, thus identifying the interlaminar space. In the thoracic spine, because of the tight space between the lamina and overlapping of the lamina, an acoustic window is infrequently visualized and cannot be used as a reliable method to identify the interlaminar space. In contrast, both the superior border of the transverse process and the step-off between lamina can be readily identified with ultrasound. Both of these landmarks align with the interlaminar space.
In clinical practice, there is significant variability in techniques used to identify the correct epidural space. Although the loss of resistance technique is the most commonly used, variability exists in methods to confirm presence in the epidural space. Once such technique routinely used at this institution is the manometry technique. This involves using a three-way stopcock connected to clear plastic tubing IV extension tubing filled with normal saline. When the loss of resistance is detected, it can be confirmed by connecting the prefilled tubing to the Tuohy needle and opening the stopcock so the fluid inside is freely flowing. If the Tuohy needle tip is located in the epidural space, the saline column will initially fall, then exhibit pulsatility associated with heartbeat and respiration.
The identification of the epidural space by respiratory and heartbeat fluctuations in the air-fluid level has been previous described. The heart rate variability is believed to be due to arteriolar pulsations transmitted within a closed epidural space, while the respiratory variation in air fluid level is believed to be due to venous engorgement of the epidural veins with changes in thoracic pressure during inspiration. In the past 30 years, a handful of studies have been published evaluating epidural pressure measurement. Many of the studies using gravity to confirm presence in epidural space also use a pressure transducer to produce a visual waveform showing increase in pressure upon entry into the ligamentum flavum, and decrease in pressure upon entry into the epidural space. Two of these studies also incorporated an audible alarm to indicate change in pressure. One study correlated epidurals placed with pressure transducers to confirm the epidural space with presence or absence of block post-op and contrast spread on CT cathetergram showing a complete correlation between pressure waveform and catheter positioned in epidural space, further establishing the validity of pressure measurement to confirm entrance in the epidural space. Epidural pressure waveform analysis has not become routine practice, likely due to equipment, cost, and time constraints. We hypothesize that the simple, rapid, and inexpensive technique of extension tubing manometry will offer similar benefits for confirmation of epidural placement and will be applicable to placement at the thoracic levels.
- Conditions
- Surgery
- Being tested
- Ultrasound Only, Manometry Only, Ultrasound Plus Manometry, Usual Care/Management
- Keywords
- Thoracic epidural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound OnlyProcedure or surgery
The anesthesia team will use ultrasound to scan on subject's upper back (thoracic spine) to identify a place to begin the epidural procedure. A pen will be used to place markings on subject's back.
Manometry OnlyProcedure or surgery
The anesthesia team will use an extra piece of tubing to confirm the epidural space one the epidural space is established.
Ultrasound Plus ManometryProcedure or surgery
The anesthesia team will use both ultrasound and manometry to assist with epidural placement.
Usual Care/ManagementProcedure or surgery
The epidural will be placed using the usual technique utilized by the anesthesiology department. The the usual care/management group will receive a sham ("fake") ultrasound exam of subject's upper back with fake pen markings placed on subject's back. The ultrasound machine will not be turned on.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Only | Active comparator | Ultrasound assisted epidural placement Receives: Procedure: Ultrasound Only |
| Manometry Only | Active comparator | Manometry confirmation in epidural placement Receives: Procedure: Manometry Only |
| Ultrasound Plus Manometry | Active comparator | Ultrasound Plus Manometry confirmation in epidural placement Receives: Procedure: Ultrasound Plus Manometry |
| Usual Care/Management | Sham comparator | Usual epidural technique placement Receives: Procedure: Usual Care/Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful thoracic epidural placement
Successful thoracic epidural placement as measured by diminished sensation to pinprick in two or more adjacent dermatomes 15 minutes after the injection of 5 mL of 1.5% lidocaine with 1:200,000 epinephrine into an epidural catheter.
Measured: 15 minutes after injection of 1.5% lidocaine
Secondary outcomes (5)
Diminished sensation to cold
Diminished sensation to cold in two or more adjacent dermatomes 15 minutes after the injection of 5 mL of 1.5% lidocaine with 1:200,000 epinephrine into an epidural catheter.
Measured: 15 minutes after injection of lidocaine
Average pain score
Mean pain scores documented in the electronic medical record
Measured: First 24 hours postoperatively
Number of attempts
Number of times the Tuohy needle is withdrawn to skin and re-inserted
Measured: During epidural placement
Procedure time
Time from start of local anesthetic infiltration to the time of Tuohy withdrawal
Measured: During epidural placement
Complications
Dural puncture, positive test response
Measured: During epidural placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start12 Jun 2018
- Primary completion30 Aug 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan Ivie, Oregon Health and Science University
- Investigators
- Ryan Ivie, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03559023
- Sponsor's protocol ID
- 18404
- Acronym
- USA-MAN-TE
- Status last verified
- Mar 2020
- First submitted
- 5 Jun 2018
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Factorial Trial of Ultrasound and Manometry to Improve the Success of Thoracic Epidural Placement
- ClinicalTrials.gov ID
- NCT03559023
- Acronym / sponsor ID
- USA-MAN-TE / 18404
- Conditions
- Surgery
- Keywords
- Thoracic epidural
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 12 Jun 2018 (actual)
- Primary completion
- 30 Aug 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 15 Jun 2018 (actual)
- 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.
To investigate the use of ultrasound and manometry to increase the success rate of thoracic epidural placement. The use of ultrasound for lumbar epidural catheter placement is well established and is thought to assist in identifying an optimal skin entry point, depth to lamina and ligamentum flavum, and needle trajectory. The use of sterile manometry tubing to demonstrate a falling and oscillating fluid column has been described as a confirmatory test in the placement of lumbar epidurals. This study will determine if the efficacy of thoracic epidural placement is improved if placement is performed with the use of either US, or manometry, or both techniques combined, compared with a standard landmark-based placement technique alone.
Detailed description
In a variety of thoracic and abdominal surgeries, thoracic epidural placement is associated with better pain relief, less opioid consumption, a decrease in adverse perioperative cardiac events, and improved intestinal perfusion and motility. Unfortunately, epidural catheter placement is challenging and is not always successful. The epidural space in the thoracic region is especially difficult to access due to the steep and inferior angulation of most of the spinous processes.
The vast majority of thoracic epidurals are placed using a landmark-based technique (i.e. without ultrasound guidance or fluoroscopy). In addition, a "loss of resistance" technique is typically used to confirm the needle has entered the epidural space. With a paramedian technique, the thoracic spinous processes are palpated (if possible), the needle is advanced through the skin just lateral to the spinous processes until lamina is contacted. The needle is then redirected medially based on an estimate of the location of the midline at the interlaminar space. The needle is then "walked" cephalad or caudad to blindly search for the interlaminar space. The depth to the lamina and interlaminar space are not known which introduces additional uncertainty in the mind of the operator, who must proceed with caution so as to not advance the needle too far and puncture the dural sac. It is not surprising that the landmark approach is associated with a significant number of unsuccessful attempts, long procedure times, and ineffective catheters, with the percentage of failed thoracic epidurals reported as high as 32%. In one study, the failure rate confirmed by both epidural waveform analysis and a sensory test after local anesthetic injection, the primary failure rate was found to be 23%-24%. A higher number of procedural attempts can also lead to an increased risk for complications including paresthesia, epidural hematoma, and dural puncture headaches. The high failure rate of this procedure highlights the need for more studies on ways to improve the techniques for thoracic epidural access.
Ultrasound (US) has proven to be useful in the imaging of the spine, and has also helped improve our ability to access the lumbar epidural space. Ultrasound measurement of the epidural space depth before epidural catheter placement decreased the rate of lumbar epidural catheter replacements, and reduced the number of epidural attempts when performed by first year residents compared to attempts without ultrasound guidance. In another study the use of ultrasound to identify the depth and location of the interlaminar and epidural space improved placement of labor epidurals with a lower number of block failures, a higher number of complete blockade, a higher rate of subject satisfaction, and lower VAS scores. Ultrasound has also been used to image the thoracic spine and epidural space.
The superior medial border of the thoracic transverse process aligns with the interlaminar space. This anatomical fact, combined with the ability to use ultrasound to identify the thoracic transverse processes and other bony landmarks forms the basis of this study. In the transverse plane, ultrasound can be used to identify the thoracic spinous processes and the midline. In the paramedian plane, the lamina, articular process and transverse process can be identified. In the lumbar spine, once the articular process is identified, a paramedian angulation of the ultrasound beam is used to identify an "acoustic window" between the lamina and into the spinal canal, thus identifying the interlaminar space. In the thoracic spine, because of the tight space between the lamina and overlapping of the lamina, an acoustic window is infrequently visualized and cannot be used as a reliable method to identify the interlaminar space. In contrast, both the superior border of the transverse process and the step-off between lamina can be readily identified with ultrasound. Both of these landmarks align with the interlaminar space.
In clinical practice, there is significant variability in techniques used to identify the correct epidural space. Although the loss of resistance technique is the most commonly used, variability exists in methods to confirm presence in the epidural space. Once such technique routinely used at this institution is the manometry technique. This involves using a three-way stopcock connected to clear plastic tubing IV extension tubing filled with normal saline. When the loss of resistance is detected, it can be confirmed by connecting the prefilled tubing to the Tuohy needle and opening the stopcock so the fluid inside is freely flowing. If the Tuohy needle tip is located in the epidural space, the saline column will initially fall, then exhibit pulsatility associated with heartbeat and respiration.
The identification of the epidural space by respiratory and heartbeat fluctuations in the air-fluid level has been previous described. The heart rate variability is believed to be due to arteriolar pulsations transmitted within a closed epidural space, while the respiratory variation in air fluid level is believed to be due to venous engorgement of the epidural veins with changes in thoracic pressure during inspiration. In the past 30 years, a handful of studies have been published evaluating epidural pressure measurement. Many of the studies using gravity to confirm presence in epidural space also use a pressure transducer to produce a visual waveform showing increase in pressure upon entry into the ligamentum flavum, and decrease in pressure upon entry into the epidural space. Two of these studies also incorporated an audible alarm to indicate change in pressure. One study correlated epidurals placed with pressure transducers to confirm the epidural space with presence or absence of block post-op and contrast spread on CT cathetergram showing a complete correlation between pressure waveform and catheter positioned in epidural space, further establishing the validity of pressure measurement to confirm entrance in the epidural space. Epidural pressure waveform analysis has not become routine practice, likely due to equipment, cost, and time constraints. We hypothesize that the simple, rapid, and inexpensive technique of extension tubing manometry will offer similar benefits for confirmation of epidural placement and will be applicable to placement at the thoracic levels.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Only | Active comparator | Procedure: Ultrasound OnlyUltrasound assisted epidural placement |
| Manometry Only | Active comparator | Procedure: Manometry OnlyManometry confirmation in epidural placement |
| Ultrasound Plus Manometry | Active comparator | Procedure: Ultrasound Plus ManometryUltrasound Plus Manometry confirmation in epidural placement |
| Usual Care/Management | Sham comparator | Procedure: Usual Care/ManagementUsual epidural technique placement |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Epidural indicated for a T4-T10 placement site
- American Society of Anesthesiologists (ASA) physical status I to IV
Key exclusion criteria (5 listed)
- Non-English speaking subjects in situations when an interpreter or consent in their native language is not available.
- Pregnant women
- Decsionally impaired
- Prisoners
- Children
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 |
|---|---|---|
| Ultrasound OnlyThe anesthesia team will use ultrasound to scan on subject's upper back (thoracic spine) to identify a place to begin the epidural procedure. A pen will be used to place markings on subject's back. | Procedure or surgery | Ultrasound Only |
| Manometry OnlyThe anesthesia team will use an extra piece of tubing to confirm the epidural space one the epidural space is established. | Procedure or surgery | Manometry Only |
| Ultrasound Plus ManometryThe anesthesia team will use both ultrasound and manometry to assist with epidural placement. | Procedure or surgery | Ultrasound Plus Manometry |
| Usual Care/ManagementThe epidural will be placed using the usual technique utilized by the anesthesiology department. The the usual care/management group will receive a sham ("fake") ultrasound exam of subject's upper back with fake pen markings placed on subject's back. The ultrasound machine will not be turned on. | Procedure or surgery | Usual Care/Management |
Primary outcome
Successful thoracic epidural placement
Time frame: 15 minutes after injection of 1.5% lidocaine
Successful thoracic epidural placement as measured by diminished sensation to pinprick in two or more adjacent dermatomes 15 minutes after the injection of 5 mL of 1.5% lidocaine with 1:200,000 epinephrine into an epidural catheter.
5 secondary outcomes
Diminished sensation to cold
Time frame: 15 minutes after injection of lidocaine
Average pain score
Time frame: First 24 hours postoperatively
Number of attempts
Time frame: During epidural placement
Procedure time
Time frame: During epidural placement
Complications
Time frame: During epidural placement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
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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.
Ryan Ivie, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound Only, Manometry Only and Ultrasound Plus Manometry in people with Surgery, run by Oregon Health and Science University 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 2 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: status not confirmed, as of the sponsor's last update on 3 Mar 2020. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ryan Ivie, MD (503-494-7641, ivie@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful thoracic epidural placement (time frame: 15 minutes after injection of 1.5% lidocaine). 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 3 Mar 2020.