Ultrasound Guided Spinal Anesthesia in Non Obese Obstetric Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Tarek Ansari, Corniche Hospital
ClinicalTrials.gov Identifier:
NCT01440400
First received: September 22, 2011
Last updated: March 11, 2013
Last verified: March 2013

September 22, 2011
March 11, 2013
October 2011
July 2012   (final data collection date for primary outcome measure)
  • The number of skin punctures [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]
    Number of times the skin is punctured by the introducer needle.
  • The number of spinal needle passes [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]
    The number of times the spinal needle tip is advanced beyond the tip of the introducer needle.
  • The time of the procedure [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]
    From skin puncture by the introducer to viewing cerebro-spinal fluid back-flow at the hub of the spinal needle.
Same as current
Complete list of historical versions of study NCT01440400 on ClinicalTrials.gov Archive Site
  • The patient satisfaction with spinal anesthesia [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    scale 0-10, 0=not satisfied, 10=completely satisfied
  • Backache after spinal needle placement, assessed within 24 hours postoperatively [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    verbal rating scale(VRS), 0-10, 0=no pain, 10=maximum pain.
Same as current
Not Provided
Not Provided
 
Ultrasound Guided Spinal Anesthesia in Non Obese Obstetric Patients
The Use of Ultrasound to Guide Spinal Anesthesia in Obstetrics. Is There an Advantage Over Landmark Technique in Non-obese Patients?

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?

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Cesarean Section
Procedure: Ultrasound guided spinal anesthesia
Using the ultrasound to identify the spinal puncture level, mid-line and the depth of the dura.
  • No Intervention: Conventional spinal anesthesia
  • Experimental: Ultrasound guided spinal anesthesia
    Intervention: Procedure: Ultrasound guided spinal anesthesia
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
October 2012
July 2012   (final data collection date for primary outcome measure)

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
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United Arab Emirates
 
NCT01440400
ch3151105
Yes
Dr. Tarek Ansari, Corniche Hospital
Corniche Hospital
Not Provided
Principal Investigator: Tarek Ansari, FFARCSI Corniche Hospital
Principal Investigator: Mounir Fayez, MD Corniche Hospital
Principal Investigator: Amr Maher, MD Corniche Hospital
Principal Investigator: Ahmed El Gamassy, MD Corniche Hospital
Corniche Hospital
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP