Influence of Lumbar Ultrasound on Resident Learning Curve for Lateral Labor Epidural Placement

NCT02826668 | Terminated

• 1 other identifier: 2013P002510
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Epidural; Lumbar Ultrasound

Outcome Measures

Primary Outcomes (10)

• 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.

  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.

  From enrollment to time of epidural placement, approximately 5 hours

• Need for assistance from additional anesthesiologist

  Need for assistance from additional anesthesiologist

  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

  From enrollment to time of epidural placement, approximately 5 hours

• Incidence of paresthesias

  Paresthesia defined as pain with needle or catheter insertion

  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)

  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.

  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.

  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.

  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.

  From enrollment to time of epidural placement, approximately 5 hours

Study Arms (2)

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.

Other: Ultrasound

Interventions

Ultrasound OTHER

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).

Ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• pregnant women
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (8)

• 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.

  PMID: 19299793 BACKGROUND

• 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.

  PMID: 15816587 BACKGROUND

• 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.

  PMID: 14656785 BACKGROUND

• 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.

  PMID: 20696564 BACKGROUND

• 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.

  PMID: 21063818 BACKGROUND

• 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.

  PMID: 24141882 BACKGROUND

• 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.

  PMID: 18319185 BACKGROUND

• 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.

  PMID: 14768920 RESULT

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Michaela K Farber, MD MS

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 26, 2016
• First Posted: July 11, 2016
• Study Start: June 1, 2014
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)