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

Cesarean Section Clinical Trial

Official title:

The Impact of Pre-Insertion Ultrasound for Lateral-Position Spinal in Cesarean Delivery: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04592926
• Other study ID #: 2020P
• Status: Recruiting
• Phase: N/A
• Start date: April 22, 2021
• Est. completion date: December 1, 2021

Study information

• Verified date: April 2021
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Training in neuraxial placement most commonly occurs with patients in the sitting position, since it is easy to master. However lateral placement may be preferred in emergent situations and for patient comfort. In order to provide safe and effective anesthesia to parturients, providers must be competent with the technique in both sitting and lateral positions.

Ultrasound examination prior to spinal placement is a safe, non-invasive method of determining depth, midline, and interspinous location. Its use may decrease the number of needle insertions and needle passes in parturients in the sitting position, however little is known about the benefit of ultrasound use in the placement of lateral spinals.

The use of lumbar ultrasound with Accuro may improve success rates, safety, and the education of residents as they learn neuraxial placement in the lateral position. This will be the first study to examine the use of Accuro for lateral neuraxial placement.

The study investigators hypothesize that lumbar ultrasound with the handheld Accuro device by an experienced provider prior to spinal insertion will result in fewer needle redirections compared to palpation of landmarks when performed by anesthesia residents or fellows.

The two arms of the study are as follows:

Group 1: Control Group: sham pre-puncture ultrasound procedure with the handheld Accuro device turned off, followed by a sham marking on the participant's back using the Accuro locator marker attached to the device.

Group 2: Ultrasound Group: pre-puncture ultrasound with Accuro followed by marking placed at the L3-4 interspace in the midline using the attached Accuro locator marker.

All ultrasound exams will be performed by an unblinded physician study investigator.

All study participants will have a spinal anesthetic in lateral position performed by one of the residents or fellows participating in the study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: December 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section
• Lumbar Ultrasound
• Spinal Anesthesia

Intervention

Device:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Needle Passes	Number of times the spinal introducer needle exits the skin and re-enters the skin at a new location	through study completion, average of 3 hours
Secondary	Procedural Time	The time from subcutaneous injection of local anesthetic prior to spinal placement until the return of cerebrospinal fluid through the spinal needle is confirmed	through study completion, average of 3 hours
Secondary	Patient Satisfaction with procedure	Patient's rating of their satisfaction with the spinal procedure using a 0-10 numeric rating scale, as measured by a blinded study investigator	through study completion, average of 3 hours