Ultrasound Guided Spinal Anesthesia in Non Obese Obstetric Patients

Study Overview
=================
Brief Summary
-----------------
The classical method for spinal anesthesia relies on the use of bony landmarks to identify the level and point of entry of the spinal needle. Over the years, in experienced hands, this method consistently proved to be successful and safe. The introduction of ultrasound to guide neuraxial anaesthesia into clinical practice was relatively slow compared to peripheral nerve blocks or central venous catheterization. This could be due to the technical difficulties posed by the bony structures surrounding the spinal cord and its dura that blocks the path of the ultrasound beam. Many anesthetists are reluctant to change their conventional landmark technique, particularly with most studies showing no change in the success rate between ultrasound guided and the landmark techniques. Several studies however showed that the ultrasound guided approach reduces the number of attempts to achieve a successful block and reduces the procedure time particularly in obese patients and those with technical difficulties. In this study the investigators are trying to answer the following question : Is there any advantage in using ultrasound to guide spinal anaesthesia in non obese obstetric patients with easily palpable bony landmarks?

Detailed Description
-----------------
Patients will be randomized using a web based randomization program into two groups: Ultrasound guided spinal anesthesia (US) & conventional spinal anesthesia (C). In both groups, the level of the third or fourth lumbar inter-space (L3/4 or L4/5) will be identified using either ultrasound (transverse and longitudinal approach) or palpation method using anatomical landmarks. All ultrasound examinations and spinal anesthesia will be performed by 3 anesthetists with experience in ultrasound guided neuraxial block (between 100 and 200 cases). The ultrasound examination will be done using Logiq e TM ultrasound machine (GE Solingen Germany) with 4C RS 2 - 5.5MHz Broadband multi-frequency probe. The predetermined point of entry for the introducer needle will be marked on the patient's back. The spinal anaesthesia will be administered with the patient in the sitting position, using a 26 gauge pencil point needle (PortexTM) with 15 mg of heavy Bupivacaine and 20 micrograms of Fentanyl. An independent observer, who is blinded to the method used to identify the point of entry of the introducer needle, will be collecting the data.The spinal anesthesia will be labeled as successful if a bilateral block to the sixth thoracic dermatome (T6) , judged by loss of cold and touch discrimination, is established 5 minutes after the spinal injection.

Official Title
-----------------
The Use of Ultrasound to Guide Spinal Anesthesia in Obstetrics. Is There an Advantage Over Landmark Technique in Non-obese Patients?

Conditions
-----------------
Cesarean Section

Intervention / Treatment
-----------------
* Procedure: Ultrasound guided spinal anesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All mothers with body mass index (BMI) equal to or less than 35 who has normal singleton pregnancy At 37 weeks gestation or more Admitted to Corniche Hospital for elective caesarean section under spinal anaesthesia Exclusion Criteria: Patients with BMI >35 Patieints with difficult anatomical landmarks Patients with neurological disease or coagulation defects Patients receiving anticoagulants Patients refusing spinal anaesthesia
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Conventional spinal anesthesia<br> | |
| Experimental: Ultrasound guided spinal anesthesia<br> | Procedure: Ultrasound guided spinal anesthesia<br>* Using the ultrasound to identify the spinal puncture level, mid-line and the depth of the dura.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of skin punctures | Number of times the skin is punctured by the introducer needle. | 30 minutes | 
| The number of spinal needle passes | The number of times the spinal needle tip is advanced beyond the tip of the introducer needle. | 30 minutes | 
| The time of the procedure | From skin puncture by the introducer to viewing cerebro-spinal fluid back-flow at the hub of the spinal needle. | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The patient satisfaction with spinal anesthesia | scale 0-10, 0=not satisfied, 10=completely satisfied | 24 hours | 
| Backache after spinal needle placement, assessed within 24 hours postoperatively | verbal rating scale(VRS), 0-10, 0=no pain, 10=maximum pain. | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ultrasound, Spinal anesthesia, Cesarean section