RecruitingPhase 3ACTRN12614000076673

Ultrasound-Assisted Neuraxial Anaesthesia for Caesarean Section

A study on the efficacy and effectiveness of ultrasound-assisted neuraxial anaesthesia versus palpation-assisted neuraxial anaesthesia for elective Caesarean section in terms of needle redirections and skin reinsertions.


Sponsor

Queensland Health

Enrollment

216 participants

Start Date

Sep 2, 2013

Study Type

Interventional

Conditions

Summary

Neuraxial anaesthesia (spinal, epidural or combined spinal-epidural anaesthesia) is the gold standard technique for elective lower segment Caesarean section (LSCS) surgery. The traditional and accepted method of performing this anaesthetic procedure involves palpation of the patient’s spinous processes and iliac crests to identify the midline and intervertebral space to appropriately insert the needle and deliver the anaesthetic. The needle is then inserted through the skin, subcutaneous fat and ligaments until the epidural and spinal space is reached. Difficulties can be encountered during this procedure due to the misidentification of the appropriate level of insertion and midline of the spine and needle contact with vertebrae, nerves and blood vessels. Ultrasound images can help identify structures beneath the skin including bone, ligament anf muscle. This study aims to: * determine the accuracy of palpation-based identification of intervertebral level and midline of the spine compared with ultrasound, * assess the efficacy of ultrasound-assisted versus palpation-assisted neuraxial anaesthesia and identify the obstetric population, and * identify the obstetric population at higher risk of difficult neuraxial insertion. Full-term pregnant (>37 weeks gestation, adult patients undergoing elective LSCS surgery who are deemed appropriate to receive a neuraxial anaesthesia will be invited to participate in the study. Patients recruited to the study will be randomised to either the palpation-assisted (control) or ultrasound-assisted (intervention) group. Prior to the performance of a combined spinal-epidural anaesthetic, an anaesthetist will identify and mark the midline and “best” lumbar intervertebral space by palpating the patients hip bones and spine. An investigator will then perform an ultrasound of the patient’s lumbar spine to identify and mark the midline “best” intervertebral space. In the control group, the palpation-identified mark will be used as the needle insertion point. In the intervention group, the ultrasound-identified mark will be used as the needle insertion point. The combined spinal-epidural anaesthetic will be performed using the same standard technique in both groups.


Eligibility

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is comparing two methods of placing the needle for spinal or epidural anaesthesia during planned caesarean section surgery. One method uses the traditional approach of feeling the spine with the hands, while the other uses an ultrasound scan to more precisely identify the correct spot before inserting the needle. Researchers want to find out if ultrasound makes the procedure easier and more accurate. You may be eligible if: - You are a woman aged 18 or older - You are at least 37 weeks pregnant - You are having a planned (elective) caesarean section - You have no medical reason against spinal or epidural anaesthesia You may NOT be eligible if: - You are less than 37 weeks pregnant - You have a medical condition that prevents spinal or epidural anaesthesia Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Ultrasound-assisted neuraxial anaesthesia is the intervention examined in this study. A pre-procedure lumbar neuraxial ultrasound is performed to identify the "best" lumbar intervertebral space for th

Ultrasound-assisted neuraxial anaesthesia is the intervention examined in this study. A pre-procedure lumbar neuraxial ultrasound is performed to identify the "best" lumbar intervertebral space for the performance of a combined spinal-epidural anaesthetic. Pen ink markings are placed on the patient's skin to identify the appropriate needle insertion point. The procedure takes 3-5 minutes.


Locations(1)

Royal Brisbane & Womens Hospital - Herston

QLD, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12614000076673