NCT03792191

Ultrasonography Versus Palpation for Spinal Anesthesia in Obese Parturients Undergoing Cesarean Delivery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 280 (actual)
• Sponsor: Mansoura University · Academic / Other
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The study will compare between preprocedural ultrasonography and the conventional palpation technique for spinal anesthesia in obese parturients undergoing elective cesarean delivery

Detailed description

This randomized, controlled, double-blind study will be conducted on ASA physical status II-III obese parturients with full-term singleton pregnancy undergoing elective cesarean delivery under spinal anesthesia. The study subjects will be assigned to 2 equal groups. In the ultrasonography group, lumbar spinal ultrasonography will be performed before administration of spinal anesthesia. In the palpation group, conventional palpation of the anatomical landmarks will be performed.

Conditions

• Anesthesia, Spinal
• Cesarean Section
• Spinal Ultrasound

Interventions

Type	Name	Description
RADIATION	Lumbar Spinal Ultrasonography	Ultrasonography of the lumbar spines using an 8-2 MHz curved array transducer. Identification of the intervertebral space with the best image. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 intervertebral spaces.
RADIATION	Sham Ultrasound Procedure	Moving the ultrasound probe on the patient's back with the machine in the freeze position.
PROCEDURE	Conventional Landmark Palpation	Conventional palpation of the anatomical landmarks. The line crossing the iliac crests (Tuffier line) is assumed to cross the spine at L4 spinous process or L3-L4 intervertebral space. Identification of the widest intervertebral space. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 intervertebral spaces.
PROCEDURE	Spinal Anesthesia	Spinal anesthesia using a 25- or 22-gauge spinal needle
DRUG	Intrathecal Bupivacaine	Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space
DRUG	Intrathecal Fentanyl	Fentanyl 15 μg will be administered in the subarachnoid space

Timeline

• Start date: 2019-01-16
• Primary completion: 2021-01-31
• Completion: 2021-01-31
• First posted: 2019-01-03
• Last updated: 2021-05-24
• Results posted: 2021-05-24

Locations

1 site across 1 country: Egypt