Evaluation of Ultrasound (US) Assistance for Anesthesia Trainees for Caesarean Section Spinal Placement

Pregnancy Clinical Trial

Official title:

Evaluation of US Assistance for Anesthesia Trainees for Spinal Placement in Parturients Having Caesarean Section: A Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01444638
• Other study ID #: R-10-594
• Secondary ID: 17529
• Status: Completed
• Phase: N/A
• First received: August 3, 2011
• Last updated: January 12, 2013
• Start date: January 2011
• Est. completion date: September 2012

Study information

• Verified date: January 2013
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

Parturients receiving spinal anesthetic for Cesarean section will be randomized to have/not have pre-spinal ultrasound examination of their back.

Description:

Parturients receiving spinal anesthetic for elective Cesarean section will be randomized to have/not have pre-spinal ultrasound examination of their back, prior to spinal insertion by anesthesia trainees.

The hypothesis is that ultrasound visualization of the patient spinal spaces will allow junior residents to correctly place the spinal needle with fewer attempts.

The null hypothesis is that there is no difference in the primary outcome (number of attempts). i.e. the investigators hypothesize that the number of attempts is not affected by ultrasound assistance. The control group will undergo spinal anesthesia with manual palpation, the standard of care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Parturient scheduled for elective spinal anesthetic for caesarean section.

2. Resident level PGY1 or PGY2.

3. Resident experience between 2-25 spinal anesthetics.

4. ASA 1-3 scheduled for elective sections

Exclusion Criteria:

1. Parturient BMI > 40.

2. Emergency C-section.

3. Previous spinal surgery or scoliosis.

4. Parturient refusal

5. Resident refusal

6. Multiple gestations

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Pregnancy

Intervention

Device:
• Ultrasound examination
Trainees will receive pre-procedure U/S guided examination of the parturient's back.

Locations

Country	Name	City	State
Canada	Victoria Hospital	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of attempts at intrathecal needle tip placement during spinal anesthesia.		Day 1	Yes
Secondary	1. Time to place spinal anesthetic (seconds), measured from introducer placement to confirmation of cerebral spinal fluid (CSF).		Day 1	No
Secondary	Space used for 1st attempt, as estimated by palpation or U/S		Day 1	No
Secondary	Number of spaces used		Day 1	Yes
Secondary	Dural depth (cm)		Day 1	No