Utilizing Ultrasound for Residents as an Aid in Epidural Placement

Not Applicable

Withdrawn

• Conditions: Epidural Placement
• Interventions: Device: Ultrasound Guided Epidural; Procedure: Standard Epidural

• Registration Number: NCT03378492
• Lead Sponsor: Yale University

Brief Summary

This randomized controlled trial will evaluate the use of ultrasound as an aid for epidural placement in residents performing all epidural techniques under direct staff anesthesiologist supervision.

Detailed Description

The purpose of this study is to assess the abilities of the "Accuro" to assist in lumbar epidural placement in patients. It is hypothesized that the use of the Accuro will result in an increase of first-attempt success rates, defined as successful epidural needle placement on the first needle insertion attempt.

Study Timeline

• Study First Submitted: 2017-12-12
• Study First Submitted QC: 2017-12-18
• Study First Posted: 2017-12-19
• Study Start: 2018-08
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-08
• Last Update Posted: 2019-01-10
• Primary Completion: 2019-11
• Study Completion: 2020-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Patients presenting for vaginal delivery
• ASA-1, ASA-2, and ASA-3
• Patients with no known back deformities
• Ability to sit upright for epidural placement
• No prior lumbar surgery
• No allergies to ultrasound gel
• Pre-pregnancy BMI >= 30

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Exclusion Criteria

• Patients < 18 years of age

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound Guided Epidural	Ultrasound Guided Epidural	Participants in this group will have epidurals placed using standard practice with the assistance of ultrasound.
Standard Epidural	Standard Epidural	Participants in this group will have epidurals placed using standard practice.

Primary Outcome Measures

Name	Time	Method
Success Rate	Baseline (at time of procedure)	Success rates are defined as successful epidural administration on the first needle insertion attempt. This outcome will be a dichotomous (yes/no) outcome.

Secondary Outcome Measures

Name	Time	Method
Time to landmark identification	Baseline (at time of procedure)	Time to landmark identification is defined as the time interval between the start of needle puncture site identification and the time to first needle puncture attempt. The start time of needle puncture site identification in both the standard group and ultrasound group corresponds to when the resident physician first places his/her hand on the patient to palpate the back.
Total technical procedure time	Baseline (at time of procedure)	Total technical procedure time is defined as the sum of (iv) Time to landmark identification, (v) Time to loss of resistance, and (vi) Time to complete epidural analgesia administration. This technical procedure time measure the time between first placing hands on the patient to the administration of analgesia.
Pain	Baseline (at time of procedure)	Pain during epidural administration: to be assessed after the completion of catheter insertion (verbal rating scale \[VRS\], 0-10, 0 = no pain, 10 = maximum pain).
Analgesia efficacy rate	Baseline (at time of procedure)	Analgesia efficacy rate: defined as VRS \<= 1 and absence of unilateral or failed block at 20 minutes after injection of the loading dose
Needle passes	Baseline (at time of procedure)	A needle pass is defined as any forward advancement or withdraw and forward redirection of the needle without withdraw from the skin. This outcome will capture the number of passes.
Needle insertion attempts	Baseline (at time of procedure)	The number of needle insertion attempts is defined as advancement of the needle through the skin in an effort to enter the epidural space; a needle requiring withdrawal from the skin for reinsertion is to be counted as an additional insertion attempt.
Accuracy of needle insertion	Baseline (at time of procedure)	The accuracy of needle insertion location is determined by the need to redirect (different angle) or reinsert the needle (different skin puncture site). This outcome will describe qualitatively the accuracy of the needle placement.
Vertebral level of epidural placement	Baseline (at time of procedure)	Vertebral level of epidural placement is a record of the vertebral level where the epidural is administered. This will be confirmed via ultrasound imaging in both standard group and ultrasound group following epidural administration.
Epidural space depth	Baseline (at time of procedure)	Epidural space depth is the depth from the skin to the epidural space as measured in centimeters (accurate to 0.1 cm).
Time to loss of resistance	Baseline (at time of procedure)	Time to loss of resistance is defined as the time interval between the first needle puncture attempt and the observation of loss of resistance.
Time to complete epidural analgesia administration	Baseline (at time of procedure)	Time to complete epidural analgesia administration is defined as the time interval between the observation of loss of resistance and administration of analgesics through the epidural catheter.
Time to comfort	Baseline (at time of procedure)	Time to comfort after administration of the loading dose will be recorded in minutes.
Patient satisfaction	Follow Up (Up to 1 day)	Patient satisfaction with the epidural administration, assessed after the administration of the loading dose (scale 0-10, 0 = not satisfied, 10 = completely satisfied).