Ultrasound Guided Spinal Anesthesia in Non Obese Obstetric Patients

NCT01440400 | Completed DMC

• 1 other identifier: ch3151105
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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?

Conditions

Cesarean Section

Keywords

Ultrasound; Spinal anesthesia; Cesarean section

Outcome Measures

Primary Outcomes (3)

• The number of skin punctures

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

  30 minutes

• 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

• 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

Secondary Outcomes (2)

• The patient satisfaction with spinal anesthesia

  24 hours

• Backache after spinal needle placement, assessed within 24 hours postoperatively

  24 hours

Study Arms (2)

Conventional spinal anesthesia

NO INTERVENTION

Ultrasound guided spinal anesthesia

EXPERIMENTAL

Procedure: Ultrasound guided spinal anesthesia

Interventions

Ultrasound guided spinal anesthesia PROCEDURE

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

Ultrasound guided spinal anesthesia

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with BMI \>35
• Patieints with difficult anatomical landmarks
• Patients with neurological disease or coagulation defects
• Patients receiving anticoagulants
• Patients refusing spinal anaesthesia

Sponsors & Collaborators

• Corniche Hospital: lead

Study Sites (1)

Corniche hospital

Abu Dhabi, 3788, United Arab Emirates

Location

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant anesthetist

Study Record Dates

• First Submitted: September 22, 2011
• First Posted: September 26, 2011
• Study Start: October 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: October 1, 2012
• Last Updated: March 12, 2013

Record last verified: 2013-03

Locations

AE (1)