Ultrasound Guided Spinal Anesthesia in Non Obese Obstetric Patients

Cesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01440400
• Other study ID #: ch3151105
• Status: Completed
• Phase: N/A
• First received: September 22, 2011
• Last updated: March 11, 2013
• Start date: October 2011
• Est. completion date: October 2012

Study information

• Verified date: March 2013
• Source: Corniche Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Arab Emirates: General Authority for Health Services for Abu Dhabi
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Cesarean Section

Intervention

Procedure:
• Ultrasound guided spinal anesthesia
Using the ultrasound to identify the spinal puncture level, mid-line and the depth of the dura.

Locations

Country	Name	City	State
United Arab Emirates	Corniche hospital	Abu Dhabi

Sponsors (1)

Lead Sponsor	Collaborator
Corniche Hospital

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of skin punctures	Number of times the skin is punctured by the introducer needle.	30 minutes	Yes
Primary	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	Yes
Primary	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	Yes
Secondary	The patient satisfaction with spinal anesthesia	scale 0-10, 0=not satisfied, 10=completely satisfied	24 hours	No
Secondary	Backache after spinal needle placement, assessed within 24 hours postoperatively	verbal rating scale(VRS), 0-10, 0=no pain, 10=maximum pain.	24 hours	Yes