Ultrasound vs Palpation for Epidurals in Labor Pain

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Disqualifiers: ASA III or IV, Severe pain, Previous spinal surgery, BMI > 37, Height < 60 inches, Scoliosis, others

Compensation: Varies

Number of Visits: 2

110 Participants Needed

Trial Summary

What is the purpose of this trial?

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?

Research Team

Philip E Hess, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Eligibility Criteria

This clinical trial is for healthy pregnant women in labor (ASA I or II) who are planning to receive an epidural for pain relief and have consented to the procedure. It's not suitable for those with certain health conditions that would exclude them from participation.

Inclusion Criteria

I am a healthy pregnant woman scheduled for an epidural or spinal block.

Exclusion Criteria

I have a serious but not life-threatening health condition.

Unable to participate in the study due to severe pain

I cannot have spinal or epidural pain relief.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Initial Phase

Randomized comparison of ultrasound versus palpation for epidural catheter insertion in laboring women

Duration not specified

1 visit (in-person)

Second Phase

Single cohort trial to assess ultrasound imaging for reliable placement below the L3 vertebra

Duration not specified

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Palpation-guided Epidural Catheter Placement
• Ultrasound-guided Epidural Catheter Placement

Trial Overview The study is comparing two methods of placing an epidural catheter: the traditional palpation technique versus using ultrasound guidance. The goal is to see if ultrasound can improve needle placement and reduce risks associated with epidural procedures.

Participant Groups

Group I: ultrasound guidance Active Control 1 Intervention

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

Group II: palpation guidance Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+