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Does Ultrasound Help Junior Anesthesia Residents With Placement of Labor Analgesia in Pregnant Patients

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ClinicalTrials.gov Identifier: NCT02747238
Recruitment Status : Terminated (lack of enrollment)
First Posted : April 21, 2016
Results First Posted : April 15, 2021
Last Update Posted : April 15, 2021
Sponsor:
Information provided by (Responsible Party):
Barbara S Orlando, Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date  ICMJE June 3, 2015
First Posted Date  ICMJE April 21, 2016
Results First Submitted Date  ICMJE February 24, 2021
Results First Posted Date  ICMJE April 15, 2021
Last Update Posted Date April 15, 2021
Actual Study Start Date  ICMJE January 29, 2018
Actual Primary Completion Date February 24, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2021)
Learning Curve of Anesthesia Residents [ Time Frame: 1 month ]
The success rate of epidural with each technique and improvement
Original Primary Outcome Measures  ICMJE
 (submitted: April 20, 2016)
Learning curve of anesthesia residents [ Time Frame: 1 month ]
The success rate of epidural with each technique and improvement
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2021)
  • Number of Attempts [ Time Frame: 30 minutes ]
    The number of attempts to locate the epidural space and midline position via ultrasound guided CSE technique.
  • Percentage of Accurate Epidural Placement [ Time Frame: 2 hours ]
    Percentage of accurate epidural placement assessed by participant reporting pain 2 hours after CSE placed
  • Number of Angle Adjustments in Space [ Time Frame: 30 minutes ]
    The number of angle adjustments of the epidural needle via ultrasound guided CSE technique.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2016)
  • Number of attempts [ Time Frame: 30 minutes ]
    The number of attempts to locate the epidural space and midline position via ultrasound guided CSE technique.
  • Accuracy of epidural placement [ Time Frame: 2 hours ]
    Pain score 2 hours after CSE placed
  • Number of angle adjustments in space [ Time Frame: 30 minutes ]
    The number of angle adjustments of the epidural needle via ultrasound guided CSE technique.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Does Ultrasound Help Junior Anesthesia Residents With Placement of Labor Analgesia in Pregnant Patients
Official Title  ICMJE Does Ultrasound-guided CSE Technique Improve Midline Placement of Epidural Needle Thereby Helping Junior Residents With Correct Placement of the Catheter Compared to the Placement Using With Anatomical Landmarks?
Brief Summary The investigators believe that ultrasound guided CSE technique will help junior resident rotating for the first time on the labor and delivery floor to place more accurately the epidural needle in the midline position as compared to placing the epidural needle via palpation of anatomical landmarks. This will result in increased ability to place the spinal component with positive cerebral spinal fluid (CSF) in the spinal needle, correct midline placement of the epidural catheter, and increase the likelihood of adequate symmetrical labor analgesia/anesthesia.
Detailed Description

Epidurals provide superior labor analgesia and anesthesia. Unfortunately, failure of epidural anesthesia and analgesia is a frequent clinical problem. In a heterogeneous cohort of 2,140 surgical patients, a failure rate of 27% for lumbar epidural was described. However, the definition of a failed epidural is broad. Different definitions include insufficient analgesia to catheter dislodgement to conversion to general anesthesia. Epidural analgesia failures may result from technical difficulties, insufficiencies or overdosing of local anesthetics, epidural septum or midline adhesions, and placement of the epidural catheter through an intervertebral foramen or into the anterior epidural space. In an imaging study of failed epidurals, incorrect catheter placement accounted for half of the failures, while the remaining patients experienced suboptimal analgesia through a correctly positioned catheter.

The incidence of overall failure was lower in patients receiving combined spinal-epidural (CSE) catheters versus epidural analgesia. In one study, the CSE technique provided decreased failure rates for labor analgesia and comparable or decreased failure rates for surgical anesthesia, when compared with reported failure rates for epidural anesthesia. It is believed that positive CSF flow in the spinal needle confirms correct epidural needle placement in the epidural space and also confirms the epidural needle to be in the midline position. Placement of the epidural needle in the midline position will minimize the incorrect placement of the catheter to one side, providing a symmetrical analgesia versus unilateral analgesia.

However, the practice of CSE and epidural catheter placement relies on the palpation of anatomical landmarks that are not always easy to feel. Therefore, the epidural needle maybe placed "off midline" despite positive loss of resistance (LOR) that causes negative CSF flow in the spinal needle and an incorrectly placed catheter. As a result, the incorrect catheter placement will result in a "failed" or suboptimal epidural analgesia.

Ultrasound has recently been utilized to facilitate lumbar epidurals and spinals. The US imaging of the lumbar spine in different scanning planes facilitates the identification of the landmarks necessary for appropriate epidural space location in pregnant patients. There are two acoustic windows that are effective for lumbar spine sonographic assessment: one seen on the transverse approach, and the other seen on the longitudinal paramedian approach. The ultrasound single-screen method using the transverse approach of the lumbar spine provides reliable information regarding the landmarks required for labor epidurals. The correct interspace and midline position are identified for correct placement of the CSE analgesia.

A previous study done by the research team, comparing "blind" vs US guidance technique. It did not show any significant difference in term of success rate or complications with either technique. However, the study was done by 4 trained physicians with lot of practice. At this level of training, the investigators did not observe any technique improvement with US. Which is why the investigators thought might have more success in showing an improvement in technique, with junior residents rotating for the first time on the floor. The idea is to see if there is any difference in their learning curve using the US versus the "blind" technique. Each resident will be their own control.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Pregnancy
Intervention  ICMJE
  • Device: Ultrasound
    The ultrasound imaging of the lumbar spine in different scanning planes facilitates the identification of the landmarks necessary for appropriate epidural space location in pregnant patients. There are two acoustic windows that are effective for lumbar spine sonographic assessment: one seen on the transverse approach, and the other seen on the longitudinal paramedian approach. The ultrasound single-screen method using the transverse approach of the lumbar spine provides reliable information regarding the landmarks required for labor epidurals. The correct interspace and midline position are identified for correct placement of the CSE analgesia.
  • Procedure: No ultrasound
    Palpation of anatomical landmarks is used for placement of labor analgesia
  • Procedure: Epidural infusion
    An epidural infusion will be started in both groups, regarding of the technique used for placement, and the same solution of Bupivacaine 0.0625% with 2mcg fentanyl/cc will be used in both groups
Study Arms  ICMJE
  • Active Comparator: Ultrasound
    Woman requests epidural for pain relief Ultrasound guided CSE placed Continuous epidural infusion started
    Interventions:
    • Device: Ultrasound
    • Procedure: Epidural infusion
  • Active Comparator: No ultrasound
    Palpation of anatomical landmarks Woman requests epidural for pain relief CSE placed using palpation of anatomical landmarks Continuous epidural infusion started
    Interventions:
    • Procedure: No ultrasound
    • Procedure: Epidural infusion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 28, 2020)
32
Original Estimated Enrollment  ICMJE
 (submitted: April 20, 2016)
288
Actual Study Completion Date  ICMJE February 24, 2020
Actual Primary Completion Date February 24, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Nulliparous
  • Term (>37 weeks gestation)
  • Vertex presentation
  • Singleton gestation
  • Ability to provide informed consent
  • Request for analgesia for labor pain
  • Maternal age 18 years or greater

Exclusion Criteria:

  • Multiparous
  • Preterm (< 37 weeks gestation)
  • Presentation other than vertex (breech, transverse)
  • Active drug/alcohol dependence
  • Previous spinal surgeries
  • Known spinal deformities
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 48 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02747238
Other Study ID Numbers  ICMJE GCO 15-1180
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Barbara S Orlando, Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE Icahn School of Medicine at Mount Sinai
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Barbara Orlando, MD Mount-Sinai Roosevelt Hospital
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP