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

Not Applicable

Terminated

• Conditions: Lumbar Ultrasound; Labor Epidural
• Interventions: Other: Ultrasound

• Registration Number: NCT02826668
• Lead Sponsor: Brigham and Women's Hospital

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.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2016-06-26
• Study First Submitted QC: 2016-07-07
• Study First Posted: 2016-07-11
• Primary Completion: 2021-03-01
• Study Completion: 2021-03-01
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-27
• Last Update Posted: 2024-09-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound	Ultrasound	Baseline and pre-puncture ultrasound with markings placed.

Primary Outcome Measures

Name	Time	Method
Depth to the epidural space (cm) from baseline ultrasound compared to pre-placement ultrasound.	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	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	From enrollment to time of epidural placement, approximately 5 hours	Need for assistance from additional anesthesiologist
Number of attempts at epidural placement	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	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.	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	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.	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.	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.	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.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States