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
  Purpose

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?


Condition Intervention
Cesarean Section
Procedure: Ultrasound guided spinal anesthesia

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: The Use of Ultrasound to Guide Spinal Anesthesia in Obstetrics. Is There an Advantage Over Landmark Technique in Non-obese Patients?

Resource links provided by NLM:


Further study details as provided by Corniche Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 150
Study Start Date: October 2011
Study Completion Date: October 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Conventional spinal anesthesia
Experimental: Ultrasound guided spinal anesthesia Procedure: Ultrasound guided spinal anesthesia
Using the ultrasound to identify the spinal puncture level, mid-line and the depth of the dura.

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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01440400

Locations
United Arab Emirates
Corniche hospital
Abu Dhabi, United Arab Emirates, 3788
Sponsors and Collaborators
Corniche Hospital
Investigators
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
  More Information

No publications provided

Responsible Party: Dr. Tarek Ansari, Consultant anesthetist, Corniche Hospital
ClinicalTrials.gov Identifier: NCT01440400     History of Changes
Other Study ID Numbers: ch3151105
Study First Received: September 22, 2011
Last Updated: March 11, 2013
Health Authority: United Arab Emirates: General Authority for Health Services for Abu Dhabi

Keywords provided by Corniche Hospital:
Ultrasound
Spinal anesthesia
Cesarean section

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014