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

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

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

Study Overview

• Status: Completed
• Conditions: Pregnancy
• Intervention / Treatment: Device: Ultrasound examination

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A5A5
      • Victoria Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultrasound; Trainees will receive pre-procedure U/S guided examination of the parturient's back.	Device: Ultrasound examination; Trainees will receive pre-procedure U/S guided examination of the parturient's back.; Other Names: M-turbo
No Intervention: Control; Control group. (Standard practice) Trainees will NOT receive pre-procedure U/S guided examination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of attempts at intrathecal needle tip placement during spinal anesthesia.	Day 1

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Investigators: Principal Investigator: Timothy P Turkstra, M. Eng, MD, UWO

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: August 3, 2011
• First Submitted That Met QC Criteria: September 30, 2011
• First Posted (Estimate): October 3, 2011

Study Record Updates

• Last Update Posted (Estimate): January 15, 2013
• Last Update Submitted That Met QC Criteria: January 12, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: pregnancy; spinal; Caesarian; section
• Other Study ID Numbers: R-10-594; 17529 (Other Identifier: REB)