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Completed

NCT Number: NCT01444638

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

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

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Key information

Conditions

Pregnancy

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Victoria Hospital

London, Ontario, N6A5A5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Parturient scheduled for elective spinal anesthetic for caesarean section.
  • Resident level PGY1 or PGY2.
  • Resident experience between 2-25 spinal anesthetics.
  • ASA 1-3 scheduled for elective sections

Exclusion criteria

  • Parturient BMI > 40.
  • Emergency C-section.
  • Previous spinal surgery or scoliosis.
  • Parturient refusal
  • Resident refusal
  • Multiple gestations

Treatment and study plan

Ultrasound examination

Device

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

Other names: M-turbo

Primary outcomes

  1. Number of attempts at intrathecal needle tip placement during spinal anesthesia.

    Time frame: Day 1

Secondary outcomes

  1. 1. Time to place spinal anesthetic (seconds), measured from introducer placement to confirmation of cerebral spinal fluid (CSF).

    Time frame: Day 1

  2. Space used for 1st attempt, as estimated by palpation or U/S

    Time frame: Day 1

  3. Number of spaces used

    Time frame: Day 1

  4. Dural depth (cm)

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 3, 2011
Registry last updated
Jan 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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