Ultrasound Guided Spinal Anesthesia in Non Obese Obstetric Patients

NCT ID: NCT01440400

Last Updated: 2013-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-10-31

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.

Conditions

Cesarean Section

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

Conventional spinal anesthesia

Group Type: NO_INTERVENTION

No interventions assigned to this group

Ultrasound guided spinal anesthesia

Group Type: EXPERIMENTAL

Ultrasound guided spinal anesthesia

Intervention Type: PROCEDURE

Using the ultrasound to identify the spinal puncture level, mid-line and the depth of the dura.

Interventions

Ultrasound guided spinal anesthesia

Using the ultrasound to identify the spinal puncture level, mid-line and the depth of the dura.

Intervention Type: PROCEDURE

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Corniche Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr. Tarek Ansari

Consultant anesthetist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tarek Ansari, FFARCSI

Role: PRINCIPAL_INVESTIGATOR

Corniche Hospital

Mounir Fayez, MD

Role: PRINCIPAL_INVESTIGATOR

Corniche Hospital

Amr Maher, MD

Role: PRINCIPAL_INVESTIGATOR

Corniche Hospital

Ahmed El Gamassy, MD

Role: PRINCIPAL_INVESTIGATOR

Corniche Hospital

Locations

Corniche hospital

Abu Dhabi, , United Arab Emirates

Countries

United Arab Emirates

Other Identifiers

ch3151105

Identifier Type: -

Identifier Source: org_study_id