Comparison Between Palpatory and Preprocedural Ultrasound Guided Techniques on Performance of Spinal Anesthesia

NCT01865955 | Completed

• 1 other identifier: 13-02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Pre-procedural ultrasound for Spinal \& Epidural anesthesia is now being increasingly performed worldwide. Pre-procedural ultrasound assessment of the spine has been shown to facilitate the placement of epidural anesthesia in pregnant women, diagnostic lumbar punctures, performance of spinal anesthesia in non-obstetric patients and accurate identification of the interspace at which the puncture is being performed. This is especially important during spinal anesthesia, where puncture below the ending of the spinal cord is recommended for safety. The purpose of this study is to compare the performance of spinal anesthesia between the pre-procedural ultrasound assessment of the spine and the traditional palpatory technique, in term pregnant women undergoing elective cesarean delivery. Furthermore, we aim to describe sonoanatomic features of the spine that could predict the ease of insertion of spinal anesthesia in that patient population. We hypothesize that in term pregnant women undergoing elective cesarean delivery, pre-procedural ultrasound assessment of the spine will improve the success rate of spinal anesthesia at first attempt, compared to the traditional palpatory technique.

Conditions

Pregnancy

Keywords

Ultrasound; Spinal anesthesia; Cesarean section

Outcome Measures

Primary Outcomes (1)

• Spinal needle redirections

  Number of redirections needed to perform a successful spinal puncture (presence of cerebrospinal fluid). A needle redirection is defined as any change in needle insertion trajectory that did not involve complete withdrawal of the needle from the patient's skin. The first needle pass will not be considered a redirection.

  15 minutes

Secondary Outcomes (6)

• Needle reinsertions

  15 minutes

• Need to change to another interspace.

  15 minutes

• Procedure time

  15 minutes

• Pain score

  15 minutes

• Intervertebral level agreement

  3 hours

Study Arms (2)

Palpation

NO INTERVENTION

Palpation will be used to determine placement of the spinal needle.

Ultrasound

EXPERIMENTAL

Ultrasound will be used prior to placement of the spinal needle.

Procedure: Ultrasound; Device: The spinal needle

Interventions

Ultrasound PROCEDURE

Ultrasound applied to the lumbar region to determine spinal needle placement.

Ultrasound

The spinal needle DEVICE

Ultrasound

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant patients scheduled to receive spinal anesthesia for elective cesarean sections
• ASA physical status 1 - 3
• Written informed consent
• Gestational age ≥ 37 weeks.

You may not qualify if:

• Patient's refusal.
• Body mass index ≥ 45
• Patient with marked spinal bony deformity (Severe scoliosis on visual inspection and previous spinal instrumentation).

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Cristian Arzola, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2013
• First Posted: May 31, 2013
• Study Start: May 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: February 3, 2014

Record last verified: 2014-01

Locations

CA (1)