Labor EpiduralNCT02826668
Influence of Lumbar Ultrasound on Resident Learning Curve for Lateral Labor Epidural Placement
A study testing Ultrasound in people with Labor Epidural and Lumbar Ultrasound, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The aim of this study is to evaluate the impact of lumbar spine ultrasound on the success rate and efficiency of labor epidural placement in the lateral position. The investigators hypothesize that ultrasound imaging of the lumbar spine of women in early labor will yield similar ultrasound results when done… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Epidural, Lumbar Ultrasound
- What is being tested?
- Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to 1 Mar 2021
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- pregnant women
- 18 years or older
- in early labor (cervix dilated < 5 cm
- pain visual analog score (VAS) < 3, or both) requesting consultation by the anesthesia team for anticipated epidural pain relief.
- Anesthesia residents or fellows who are performing the epidural technique in pregnant subjects who agree to be part of the study.
- Anesthesia residents or fellows with prior experience in the lumbar epidural technique, defined as having placed 20 or greater lumbar epidurals during their residency and prior to enrollment.
Who cannot join
- absolute contraindications of neuraxial anesthesia including patient refusal
- uncorrected coagulopathy
- infection at the skin site of epidural placement
- increased intracranial pressure, or untreated hemodynamic instability.
- In addition, patients with a history of scoliosis or spine surgery
- body mass index (BMI) >40 kg/m2
Show all 9Show fewer
- allergy to local anesthetic, or allergy to opioids will be excluded.
- Anesthesiologists
- individuals who do not want to participate in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Pre-insertion Ultrasound Guidance for Labor Epidural Placement in the Lateral Position: A Randomized Controlled Trial of Image Reproducibility During Labor and Impact on Resident Learning Curve
The aim of this study is to evaluate the impact of lumbar spine ultrasound on the success rate and efficiency of labor epidural placement in the lateral position. The investigators hypothesize that ultrasound imaging of the lumbar spine of women in early labor will yield similar ultrasound results when done immediately prior to epidural placement. The investigators also hypothesize that the use of ultrasound with landmarks marked and depth to the epidural space estimated will facilitate epidural placement in terms of both efficiency (time required for placement) and efficacy of pain relief.
Read the detailed description
Several studies have demonstrated a significant benefit in pre-procedural ultrasound for epidural placement by anesthesia residents, particularly when performed in the obese population. To the investigators knowledge, however, no studies have evaluated this teaching modality for the lumber epidural technique in the lateral position. Formalizing the educational process for this less frequently performed, highly technical and critical skill may have a profound impact on trainee learning curves, and may enhance the overall success and efficiency of epidural placement, quality of analgesia provided, and safety of the procedure.
- Conditions
- Labor Epidural, Lumbar Ultrasound
- Being tested
- Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundOther
A baseline lumbar ultrasound in a standardized lateral position (by bed markings) will be performed with the midline and L3-L4 interspace marked, and estimated depth to the epidural space recorded. A second lateral lumbar ultrasound will be performed immediately prior to placement at the time of epidural request. The bed position will be standardized with lines drawn down the back, at the flexion of the knee, and heel of the foot. The sonographic measurements will include the midline, the L3-4 interspace, (both marked at the skin surface), and the measured depth to the ligamentum flavum (in centimeters).
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Baseline ultrasound only, with no markings placed. No ultrasound prior to epidural placement. |
| Ultrasound | Experimental | Baseline and pre-puncture ultrasound with markings placed. Receives: Other: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depth to the epidural space (cm) from baseline ultrasound compared to pre-placement ultrasound.
Measured depth to the epidural space (cm) from baseline ultrasound compared to pre-placement ultrasound, measured with a 2-5 MHz curvilinear ultrasound probe at the lumbar spine, midline, at level L3-4.
Measured: From enrollment to time of epidural placement, approximately 5 hours
Time required for epidural placement
Time required for placement (T0 = insertion of needle for subcutaneous lidocaine infusion prior to epidural needle placement). Tfinal = time at complete removal of Weiss epidural needle after catheter is threaded into the epidural space.
Measured: From enrollment to time of epidural placement, approximately 5 hours
Need for assistance from additional anesthesiologist
Need for assistance from additional anesthesiologist
Measured: From enrollment to time of epidural placement, approximately 5 hours
Number of attempts at epidural placement
defined as number of times the Weiss epidural needle enters the skin
Measured: From enrollment to time of epidural placement, approximately 5 hours
Incidence of paresthesias
Paresthesia defined as pain with needle or catheter insertion
Measured: From enrollment to time of epidural placement, approximately 5 hours
Labor pain at time of 30 minutes after placement is complete.
Labor pain rated on a visual analog scale (VAS)
Measured: From enrollment to time of epidural placement, approximately 5 hours, plus 30 minutes.
Rate of epidural replacement for inadequate analgesia
Inadequate analgesia determined as VAS >3 despite catheter adjustment and/or epidural dose adjustment.
Measured: From enrollment to time of epidural placement, approximately 5 hours
Rate of inadvertent dural puncture at the time of placement.
Defined as cerebrospinal fluid aspiration through needle or catheter.
Measured: From enrollment to time of epidural placement, approximately 5 hours
Midline measurement from baseline ultrasound compared to pre-placement ultrasound.
Measured midline (anatomical marking) from baseline ultrasound compared to pre-placement ultrasound, measured with a 2-5 MHz curvilinear ultrasound probe at the lumbar spine, midline.
Measured: From enrollment to time of epidural placement, approximately 5 hours
L3-L4 lumbar spine level measured from baseline ultrasound compared to pre-placement ultrasound.
Measured L3-L4 lumbar spine level from baseline ultrasound compared to pre-placement ultrasound, measured with a 2-5 MHz curvilinear ultrasound probe at the lumbar spine, paramedic.
Measured: From enrollment to time of epidural placement, approximately 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startJun 2014
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Why it stopped: The study was terminated due to loss of study staff and inability to recruit patients during COVID 19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Labor EpiduralStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michaela Kristina Farber, MD, Brigham and Women's Hospital
- Investigators
- Michaela K Farber, MD MS, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02826668
- Sponsor's protocol ID
- 2013P002510
- Status last verified
- Sep 2024
- First submitted
- 26 Jun 2016
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Mhyre JM, Greenfield ML, Tsen LC, Polley LS. A systematic review of randomized controlled trials that evaluate strategies to avoid epidural vein cannulation during obstetric epidural catheter placement. Anesth Analg. 2009 Apr;108(4):1232-42. doi: 10.1213/ane.0b013e318198f85e.
PubMed 19299793Harney D, Moran CA, Whitty R, Harte S, Geary M, Gardiner J. Influence of posture on the incidence of vein cannulation during epidural catheter placement. Eur J Anaesthesiol. 2005 Feb;22(2):103-6. doi: 10.1017/s0265021505000190.
PubMed 15816587Grau T, Bartusseck E, Conradi R, Martin E, Motsch J. Ultrasound imaging improves learning curves in obstetric epidural anesthesia: a preliminary study. Can J Anaesth. 2003 Dec;50(10):1047-50. doi: 10.1007/BF03018371.
PubMed 14656785Vallejo MC, Phelps AL, Singh S, Orebaugh SL, Sah N. Ultrasound decreases the failed labor epidural rate in resident trainees. Int J Obstet Anesth. 2010 Oct;19(4):373-8. doi: 10.1016/j.ijoa.2010.04.002. Epub 2010 Aug 8.
PubMed 20696564Balki M. Locating the epidural space in obstetric patients-ultrasound a useful tool: continuing professional development. Can J Anaesth. 2010 Dec;57(12):1111-26. doi: 10.1007/s12630-010-9397-y. Epub 2010 Nov 11. English, French.
PubMed 21063818Sahin T, Balaban O, Sahin L, Solak M, Toker K. A randomized controlled trial of preinsertion ultrasound guidance for spinal anaesthesia in pregnancy: outcomes among obese and lean parturients: ultrasound for spinal anesthesia in pregnancy. J Anesth. 2014 Jun;28(3):413-9. doi: 10.1007/s00540-013-1726-1. Epub 2013 Oct 20.
PubMed 24141882Carvalho JC. Ultrasound-facilitated epidurals and spinals in obstetrics. Anesthesiol Clin. 2008 Mar;26(1):145-58, vii-viii. doi: 10.1016/j.anclin.2007.11.007.
PubMed 18319185Grau T, Leipold RW, Fatehi S, Martin E, Motsch J. Real-time ultrasonic observation of combined spinal-epidural anaesthesia. Eur J Anaesthesiol. 2004 Jan;21(1):25-31. doi: 10.1017/s026502150400105x.
PubMed 14768920
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-insertion Ultrasound Guidance for Labor Epidural Placement in the Lateral Position: A Randomized Controlled Trial of Image Reproducibility During Labor and Impact on Resident Learning Curve
- ClinicalTrials.gov ID
- NCT02826668
- Acronym / sponsor ID
- 2013P002510
- Conditions
- Labor Epidural, Lumbar Ultrasound
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to loss of study staff and inability to recruit patients during COVID 19
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 11 Jul 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.
The aim of this study is to evaluate the impact of lumbar spine ultrasound on the success rate and efficiency of labor epidural placement in the lateral position. The investigators hypothesize that ultrasound imaging of the lumbar spine of women in early labor will yield similar ultrasound results when done immediately prior to epidural placement. The investigators also hypothesize that the use of ultrasound with landmarks marked and depth to the epidural space estimated will facilitate epidural placement in terms of both efficiency (time required for placement) and efficacy of pain relief.
Detailed description
Several studies have demonstrated a significant benefit in pre-procedural ultrasound for epidural placement by anesthesia residents, particularly when performed in the obese population. To the investigators knowledge, however, no studies have evaluated this teaching modality for the lumber epidural technique in the lateral position. Formalizing the educational process for this less frequently performed, highly technical and critical skill may have a profound impact on trainee learning curves, and may enhance the overall success and efficiency of epidural placement, quality of analgesia provided, and safety of the procedure.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Baseline ultrasound only, with no markings placed. No ultrasound prior to epidural placement. |
| Ultrasound | Experimental | Other: UltrasoundBaseline and pre-puncture ultrasound with markings placed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- pregnant women
- 18 years or older
- in early labor (cervix dilated < 5 cm
- pain visual analog score (VAS) < 3, or both) requesting consultation by the anesthesia team for anticipated epidural pain relief.
- Anesthesia residents or fellows who are performing the epidural technique in pregnant subjects who agree to be part of the study.
Key exclusion criteria (9 listed)
- absolute contraindications of neuraxial anesthesia including patient refusal
- uncorrected coagulopathy
- infection at the skin site of epidural placement
- increased intracranial pressure, or untreated hemodynamic instability.
- In addition, patients with a history of scoliosis or spine surgery
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 |
|---|---|---|
| UltrasoundA baseline lumbar ultrasound in a standardized lateral position (by bed markings) will be performed with the midline and L3-L4 interspace marked, and estimated depth to the epidural space recorded. A second lateral lumbar ultrasound will be performed immediately prior to placement at the time of epidural request. The bed position will be standardized with lines drawn down the back, at the flexion of the knee, and heel of the foot. The sonographic measurements will include the midline, the L3-4 interspace, (both marked at the skin surface), and the measured depth to the ligamentum flavum (in centimeters). | Other | Ultrasound |
Primary outcome
Depth to the epidural space (cm) from baseline ultrasound compared to pre-placement ultrasound.
Time frame: From enrollment to time of epidural placement, approximately 5 hours
Measured depth to the epidural space (cm) from baseline ultrasound compared to pre-placement ultrasound, measured with a 2-5 MHz curvilinear ultrasound probe at the lumbar spine, midline, at level L3-4.
Time required for epidural placement
Time frame: From enrollment to time of epidural placement, approximately 5 hours
Time required for placement (T0 = insertion of needle for subcutaneous lidocaine infusion prior to epidural needle placement). Tfinal = time at complete removal of Weiss epidural needle after catheter is threaded into the epidural space.
Need for assistance from additional anesthesiologist
Time frame: From enrollment to time of epidural placement, approximately 5 hours
Need for assistance from additional anesthesiologist
Number of attempts at epidural placement
Time frame: From enrollment to time of epidural placement, approximately 5 hours
defined as number of times the Weiss epidural needle enters the skin
Incidence of paresthesias
Time frame: From enrollment to time of epidural placement, approximately 5 hours
Paresthesia defined as pain with needle or catheter insertion
Labor pain at time of 30 minutes after placement is complete.
Time frame: From enrollment to time of epidural placement, approximately 5 hours, plus 30 minutes.
Labor pain rated on a visual analog scale (VAS)
Rate of epidural replacement for inadequate analgesia
Time frame: From enrollment to time of epidural placement, approximately 5 hours
Inadequate analgesia determined as VAS >3 despite catheter adjustment and/or epidural dose adjustment.
Rate of inadvertent dural puncture at the time of placement.
Time frame: From enrollment to time of epidural placement, approximately 5 hours
Defined as cerebrospinal fluid aspiration through needle or catheter.
Midline measurement from baseline ultrasound compared to pre-placement ultrasound.
Time frame: From enrollment to time of epidural placement, approximately 5 hours
Measured midline (anatomical marking) from baseline ultrasound compared to pre-placement ultrasound, measured with a 2-5 MHz curvilinear ultrasound probe at the lumbar spine, midline.
L3-L4 lumbar spine level measured from baseline ultrasound compared to pre-placement ultrasound.
Time frame: From enrollment to time of epidural placement, approximately 5 hours
Measured L3-L4 lumbar spine level from baseline ultrasound compared to pre-placement ultrasound, measured with a 2-5 MHz curvilinear ultrasound probe at the lumbar spine, paramedic.
Results and safety
The study was stopped early (reason given: The study was terminated due to loss of study staff and inability to recruit patients during COVID 19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Background: PubMed 19299793Mhyre JM, Greenfield ML, Tsen LC, Polley LS. A systematic review of randomized controlled trials that evaluate strategies to avoid epidural vein cannulation during obstetric epidural catheter placement. Anesth Analg. 2009 Apr;108(4):1232-42. doi: 10.1213/ane.0b013e318198f85e.
- Background: PubMed 15816587Harney D, Moran CA, Whitty R, Harte S, Geary M, Gardiner J. Influence of posture on the incidence of vein cannulation during epidural catheter placement. Eur J Anaesthesiol. 2005 Feb;22(2):103-6. doi: 10.1017/s0265021505000190.
- Background: PubMed 14656785Grau T, Bartusseck E, Conradi R, Martin E, Motsch J. Ultrasound imaging improves learning curves in obstetric epidural anesthesia: a preliminary study. Can J Anaesth. 2003 Dec;50(10):1047-50. doi: 10.1007/BF03018371.
- Background: PubMed 20696564Vallejo MC, Phelps AL, Singh S, Orebaugh SL, Sah N. Ultrasound decreases the failed labor epidural rate in resident trainees. Int J Obstet Anesth. 2010 Oct;19(4):373-8. doi: 10.1016/j.ijoa.2010.04.002. Epub 2010 Aug 8.
- Background: PubMed 21063818Balki M. Locating the epidural space in obstetric patients-ultrasound a useful tool: continuing professional development. Can J Anaesth. 2010 Dec;57(12):1111-26. doi: 10.1007/s12630-010-9397-y. Epub 2010 Nov 11. English, French.
- Background: PubMed 24141882Sahin T, Balaban O, Sahin L, Solak M, Toker K. A randomized controlled trial of preinsertion ultrasound guidance for spinal anaesthesia in pregnancy: outcomes among obese and lean parturients: ultrasound for spinal anesthesia in pregnancy. J Anesth. 2014 Jun;28(3):413-9. doi: 10.1007/s00540-013-1726-1. Epub 2013 Oct 20.
- Background: PubMed 18319185Carvalho JC. Ultrasound-facilitated epidurals and spinals in obstetrics. Anesthesiol Clin. 2008 Mar;26(1):145-58, vii-viii. doi: 10.1016/j.anclin.2007.11.007.
- Results publication: PubMed 14768920Grau T, Leipold RW, Fatehi S, Martin E, Motsch J. Real-time ultrasonic observation of combined spinal-epidural anaesthesia. Eur J Anaesthesiol. 2004 Jan;21(1):25-31. doi: 10.1017/s026502150400105x.
- Individual participant dataSharing planned: No
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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.
Michaela K Farber, MD MS principal investigator
Brigham and Women's Hospital
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 in people with Labor Epidural and Lumbar Ultrasound, run by Brigham and Women's Hospital 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 6 inclusion and 9 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: stopped early, as of the sponsor's last update on 1 Oct 2024. 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 was stopped early (reason given: The study was terminated due to loss of study staff and inability to recruit patients during COVID 19). Results are not available in the source record.
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?
Depth to the epidural space (cm) from baseline ultrasound compared to pre-placement ultrasound. (time frame: From enrollment to time of epidural placement, approximately 5 hours). The study lists 10 primary outcomes in all. 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 NCT02826668, which also lists 8 linked publications.
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 1 Oct 2024.