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

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Status: Completed

Conditions: Pregnancy

Treatments: Device: The spinal needle; Procedure: Ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT01865955

13-02

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Palpation

No Intervention group

Description:

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

Ultrasound

Experimental group

Description:

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

Treatment:

Procedure: Ultrasound

Device: The spinal needle