Recruiting

Ultrasound

Sponsor:

Brigham and Women's Hospital

Code:

NCT04592926

Conditions

Cesarean Section

Spinal Anesthesia

Lumbar Ultrasound

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Accuro SpineNav3D

Sham

Study Details

Brief summary:

The purpose of this study is to evaluate the impact of lumbar ultrasound anatomic mapping using the Accuro device on the number of needle redirections, when performing spinal anesthesia in the lateral decubitus position on patients undergoing elective cesarean delivery.

Conditions

Cesarean Section

Spinal Anesthesia

Lumbar Ultrasound

Study ID

NCT04592926

Start date

Apr 22, 2021

Status verified date

Apr, 2021

Completion date

Dec 1, 2021

Anticipated

Primary completion date

Oct 1, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • pregnant women
  • 18 years or older
  • singleton pregnancy
  • at least 37 weeks gestational age
  • American Society of Anesthesiologists (ASA) Classification II
  • body mass index (BMI) <35 kg/m2
  • plan for elective and scheduled cesarean section with spinal anesthesia

Exclusion Criteria:

  • patient refusal of spinal anesthesia
  • uncorrected coagulopathy
  • infection at the skin site of spinal placement
  • increased intracranial pressure
  • untreated hemodynamic instability
  • history of scoliosis or spine surgery
  • BMI >/=35 kg/m2
  • allergy to local anesthetic
  • allergy to opioids

Study Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Accuro ultrasound

sham comparator: Control

Interventions

Accuro SpineNav3D

The intervention will consist of a pre-procedural scan of the lumbar spine using the handheld image guidance device, Accuro, to determine spinal landmarks and anticipated depth of the intrathecal space.

Sham

The sham group will receive a pre-procedure sham scan (the handheld image guidance Accuro device will be placed on the back, but it will be turned off) followed by sham marking on the subject's back.

Primary outcome measure

  • Number of Needle Redirections [ Time Frame: through study completion, average of 3 hours ]

Central Contacts and Locations

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Naida M Cole, MD

617-732-5000nmcole@partners.org

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Apr 26, 2021

Last verified

Apr, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2021-04-26.