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

NCT02271100 | Completed Results FDA Device

• 1 other identifier: 2014P000267
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Labor Pain

Outcome Measures

Primary Outcomes (1)

• Placement Below L3 Vertebra

  Percentage of participants with catheters placed below the L3 Vertebra

  immediately post epidural catheter placement

Secondary Outcomes (2)

• Time to Placement

  During the procedure

• Success of the Epidural Catheter Placement

  immediately post epidural catheter placement up to 30 minutes

Study Arms (2)

palpation guidance

PLACEBO COMPARATOR

placement of spinal or combined spinal epidural needle using palpation to guide entry position

Device: palpation guidance

ultrasound guidance

ACTIVE COMPARATOR

placement of spinal or combined spinal epidural using ultrasound to guide entry position

Device: ultrasound guidance

Interventions

ultrasound guidance DEVICE

use of ultrasound for entry position estimation

ultrasound guidance

palpation guidance DEVICE

use of palpation for position estimation

palpation guidance

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Isreal Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Research Compliance
• Organization: BIDMC

BILH-researchcompliance@bilh.org

617-667-1897

Study Officials

• Philip E Hess, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: randomized blinded comparison of two methods to identify landmarks for a procedure

Study Record Dates

• First Submitted: October 17, 2014
• First Posted: October 22, 2014
• Study Start: October 25, 2016
• Primary Completion: December 31, 2018
• Study Completion: January 1, 2025
• Last Updated: March 3, 2026
• Results First Posted: March 3, 2026

Record last verified: 2026-03

Locations

US (1)