Clinical trial NCT02826668: Influence of Lumbar Ultrasound on Resident Learning Curve for Lateral Labor Epidural Placement
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Labor Epidural
Lumbar Ultrasound
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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 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.

Eligibility criteria: Pregnant Subjects

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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
* allergy to local anesthetic, or allergy to opioids will be excluded.

Anesthesiologists

Inclusion criteria:

* 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.

Exclusion criteria:

* individuals who do not want to participate in the study.

Primary outcomes:
measure: Depth to the epidural space (cm) from baseline ultrasound compared to pre-placement ultrasound.
timeFrame: From enrollment to time of epidural placement, approximately 5 hours
measure: Time required for epidural placement
timeFrame: From enrollment to time of epidural placement, approximately 5 hours
measure: Need for assistance from additional anesthesiologist
timeFrame: From enrollment to time of epidural placement, approximately 5 hours
measure: Number of attempts at epidural placement
timeFrame: From enrollment to time of epidural placement, approximately 5 hours
measure: Incidence of paresthesias
timeFrame: From enrollment to time of epidural placement, approximately 5 hours
measure: Labor pain at time of 30 minutes after placement is complete.
timeFrame: From enrollment to time of epidural placement, approximately 5 hours, plus 30 minutes.
measure: Rate of epidural replacement for inadequate analgesia
timeFrame: From enrollment to time of epidural placement, approximately 5 hours
measure: Rate of inadvertent dural puncture at the time of placement.
timeFrame: From enrollment to time of epidural placement, approximately 5 hours
measure: Midline measurement from baseline ultrasound compared to pre-placement ultrasound.
timeFrame: From enrollment to time of epidural placement, approximately 5 hours
measure: L3-L4 lumbar spine level measured from baseline ultrasound compared to pre-placement ultrasound.
timeFrame: From enrollment to time of epidural placement, approximately 5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Michaela K Farber, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Harney 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.
citation: Grau 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.
citation: Vallejo 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.
citation: Balki 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.
citation: Sahin 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.
citation: Carvalho 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.
citation: Grau 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.