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

NCT ID: NCT01865955

Last Updated: 2014-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2013-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Palpation

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Ultrasound

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

Group Type: EXPERIMENTAL

Ultrasound

Intervention Type: PROCEDURE

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

The spinal needle

Intervention Type: DEVICE

Interventions

Ultrasound

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

Intervention Type: PROCEDURE

The spinal needle

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cristian Arzola, MD

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Locations

Mount Sinai Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

13-02

Identifier Type: -

Identifier Source: org_study_id