Pre-Insertion Ultrasound for Lateral-Position Spinal in Cesarean Delivery

NCT04592926 | Unknown FDA Device

• 1 other identifier: 2020P
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of Needle Redirections

  Number of times the angle of the spinal introducer needle is adjusted, without exiting and re-entering the skin

  through study completion, average of 3 hours

Secondary Outcomes (3)

• Number of Needle Passes

  through study completion, average of 3 hours

• Procedural Time

  through study completion, average of 3 hours

• Patient Satisfaction with procedure

  through study completion, average of 3 hours

Study Arms (2)

Accuro ultrasound

EXPERIMENTAL

Device: Accuro SpineNav3D

Control

SHAM COMPARATOR

Other: Sham

Interventions

Accuro SpineNav3D DEVICE

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.

Also known as: Accuro

Accuro ultrasound

Sham OTHER

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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• pregnant women
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Interventions

salicylhydroxamic acid

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patient and observer who collects the outcome data will be blinded to group allocation. The anesthesiologist caring for the patient and the resident/fellow performing the spinal anesthetic will be unblinded.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anesthesiologist, Principal Investigator

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 19, 2020
• Study Start: April 22, 2021
• Primary Completion: October 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 26, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)