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

Not Applicable

Completed

• Conditions: Pregnancy
• Interventions: Device: Ultrasound examination

• Registration Number: NCT01444638
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-08-03
• Study First Submitted QC: 2011-09-30
• Study First Posted: 2011-10-03
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-12
• Last Update Posted: 2013-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound	Ultrasound examination	Trainees will receive pre-procedure U/S guided examination of the parturient's back.

Primary Outcome Measures

Name	Time	Method
Number of attempts at intrathecal needle tip placement during spinal anesthesia.	Day 1

Secondary Outcome Measures

Name	Time	Method
1. Time to place spinal anesthetic (seconds), measured from introducer placement to confirmation of cerebral spinal fluid (CSF).	Day 1
Space used for 1st attempt, as estimated by palpation or U/S	Day 1
Number of spaces used	Day 1
Dural depth (cm)	Day 1

Trial Locations

Locations (1)

Victoria Hospital; 🇨🇦 London, Ontario, Canada