Assessment of the Use of Ultrasound for Epidural Catheter Placement and Comparison With Palpation Technique

This study is intended to determine whether ultrasound imaging can improve the ability to place a spinal or epidural needle in obstetric anesthesia. By evaluating the use of ultrasound for the placement of epidural catheters the investigators hope to answer two questions:

1. How does the traditional technique based on palpation compare to one using ultrasound to place an epidural catheter? 2. Does ultrasound reduce one potential risk in epidural placement?

Study Overview

• Status: Active, not recruiting
• Conditions: Labor Pain
• Intervention / Treatment: Device: palpation guidance; Device: ultrasound guidance

Detailed Description

This study contains two phases:

1. A prospective, randomized, blinded comparison of ultrasound imaging versus palpation for epidural catheter insertion in laboring women.
2. A prospective, single cohort, blinded trial to assess whether ultrasound imaging provides a reliable placement below the L3 vertebra.

The initial phase of the investigation will be a randomized comparison of ultrasound versus palpation. Patients will be enrolled in early labor and will be randomized to have their epidural placed with either technique. The technique will be chosen by computer-generated randomization list maintained in opaque sequentially numbered envelopes. Description of the placement technique is below. The primary outcome will be the number of epidural catheters inserted above the intended insertion site. The investigators will also assess the total time required for epidural catheter placement, number of attempts for successful insertion, effectiveness of the epidural catheter for labor pain control.

Following completion of enrollment of the first phase, the second phase of the investigation will enroll patients only into the single-cohort ultrasound arm. The study will use the same methodology as the initial phase, but without randomization due to a single cohort. The primary outcome will be the absolute number of epidural catheters inserted above the L3 vertebral body. The investigators will also assess the effectiveness of the ultrasound markings for guiding placement.

Procedure placement technique After written, informed consent, and standard patient preparation, the epidural catheter will be placed with the patient in the sitting position by a junior resident. In the ultrasound arm, the patient will be first imaged using an appropriate probe, and the identified ultrasound landmarks marked on the skin. The skin will be prepped in the usual fashion, and the needle will be inserted at the identified site and direction determined by ultrasound. In the palpation arm, the skin will be prepped and the needle will be inserted using palpation-identified landmarks to guide the needle. All catheters will be intended to be placed at the L4-L5 interspace as the primary attempt. The L3-L4 interspace will be used as a secondary attempt.

Assessment of final position After insertion of the epidural catheter and administration of the pain relief medication, patients in both groups will be examined by a blinded observer using ultrasound to determine the catheter insertion site and the likely insertion interspace.

If, however, the investigators discover that the use of ultrasound for placement of the epidural catheter may present greater risk than previously anticipated to the pregnant woman or fetus, then the investigators will stop the study after phase 1 and not proceed with phase 2.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Isreal Deaconess Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy ASA I or II parturient
• Will be receiving neuraxial placement for labor, having been consented for the procedure

Exclusion Criteria:

• ASA III or IV
• Unable to participate in the study due to severe pain
• Contraindications to neuraxial analgesia
• Previous spinal surgery in the lumbar or sacral area (L1 through Sacrum)
• BMI greater than 37
• Height less than 60 inches
• Significant scoliosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: palpation guidance; placement of spinal or combined spinal epidural needle using palpation to guide entry position	Device: palpation guidance; use of palpation for position estimation
Active Comparator: ultrasound guidance; placement of spinal or combined spinal epidural using ultrasound to guide entry position	Device: ultrasound guidance; use of ultrasound for entry position estimation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Placement below L3 vertebra	Percentage of catheters placed below the target location	immediate

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to placement	Minutes from start of procedure to the end of the procedure	immediate
Success of the epidural catheter placement	Relief of labor pain defined by verbal pain score less than 4 after administration of medication	immediate

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Investigators: Principal Investigator: Philip E Hess, MD, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2016
• Primary Completion (Actual): December 31, 2018
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: October 17, 2014
• First Submitted That Met QC Criteria: October 20, 2014
• First Posted (Estimated): October 22, 2014

Study Record Updates

• Last Update Posted (Actual): May 7, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain
• Other Study ID Numbers: 2014P000267

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No