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Completed

NCT Number: NCT01440400

Ultrasound Guided Spinal Anesthesia in Non Obese Obstetric 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?

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Key information

Conditions

Cesarean Section

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Corniche hospital

Abu Dhabi, 3788, United Arab Emirates

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound guided spinal anesthesia

Procedure

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

Primary outcomes

  1. The number of skin punctures

    Time frame: 30 minutes

    Number of times the skin is punctured by the introducer needle.

  2. The number of spinal needle passes

    Time frame: 30 minutes

    The number of times the spinal needle tip is advanced beyond the tip of the introducer needle.

  3. The time of the procedure

    Time frame: 30 minutes

    From skin puncture by the introducer to viewing cerebro-spinal fluid back-flow at the hub of the spinal needle.

Secondary outcomes

  1. The patient satisfaction with spinal anesthesia

    Time frame: 24 hours

    scale 0-10, 0=not satisfied, 10=completely satisfied

  2. Backache after spinal needle placement, assessed within 24 hours postoperatively

    Time frame: 24 hours

    verbal rating scale(VRS), 0-10, 0=no pain, 10=maximum pain.

Sponsors and collaborators

Lead sponsor

Corniche Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 26, 2011
Registry last updated
Mar 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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