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

NCT ID: NCT02271100

Last Updated: 2025-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-25
• Study Completion Date: 2025-01-01

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?

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.

Conditions

Labor Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

palpation guidance

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

Group Type: PLACEBO_COMPARATOR

palpation guidance

Intervention Type: DEVICE

use of palpation for position estimation

ultrasound guidance

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

Group Type: ACTIVE_COMPARATOR

ultrasound guidance

Intervention Type: DEVICE

use of ultrasound for entry position estimation

Interventions

ultrasound guidance

use of ultrasound for entry position estimation

Intervention Type: DEVICE

palpation guidance

use of palpation for position estimation

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Phillip Hess

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Philip E Hess, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Beth Isreal Deaconess Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2014P000267

Identifier Type: -

Identifier Source: org_study_id