Clinical trial NCT01440400: Ultrasound Guided Spinal Anesthesia in Non Obese Obstetric Patients
Official title: The Use of Ultrasound to Guide Spinal Anesthesia in Obstetrics. Is There an Advantage Over Landmark Technique in Non-obese Patients?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section
Keywords: Ultrasound
Spinal anesthesia
Cesarean section
Lead sponsor: Corniche Hospital
Sponsor class: OTHER
First posted: 2011-09-26
Enrollment: 150
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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

Primary outcomes:
measure: The number of skin punctures
timeFrame: 30 minutes
measure: The number of spinal needle passes
timeFrame: 30 minutes
measure: The time of the procedure
timeFrame: 30 minutes
Secondary outcomes:
measure: The patient satisfaction with spinal anesthesia
timeFrame: 24 hours
measure: Backache after spinal needle placement, assessed within 24 hours postoperatively
timeFrame: 24 hours
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: Corniche hospital
Study officials:
affiliation: Corniche Hospital
name: Tarek Ansari, FFARCSI
role: PRINCIPAL_INVESTIGATOR
affiliation: Corniche Hospital
name: Mounir Fayez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Corniche Hospital
name: Amr Maher, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Corniche Hospital
name: Ahmed El Gamassy, MD
role: PRINCIPAL_INVESTIGATOR
References: