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

Mansoura University

Status: Completed

Conditions: Cesarean Section; Anesthesia, Spinal; Spinal Ultrasound

Treatments: Procedure: Conventional Landmark Palpation; Radiation: Lumbar Spinal Ultrasonography; Drug: Intrathecal Bupivacaine; Drug: Intrathecal Fentanyl; Procedure: Spinal Anesthesia; Radiation: Sham Ultrasound Procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT03792191

MD.18.02.29

Details and patient eligibility

About

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

Full 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.

Enrollment: 280 patients

Sex: Female

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• American Society of Anesthesiologists physical status II-III parturients
• Full term singleton pregnancy
• Body mass index ≥ 35 Kg/m2

Exclusion criteria

• Age < 19 years
• Women presenting in labor
• Contraindications to neuraxial anesthesia (Coagulopathy, increased intracranial pressure, or local skin infection)
• Significant spinal deformities or previous spinal surgery
• Preeclampsia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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280 participants in 2 patient groups

Ultrasonography

Experimental group

Description:

Preprocedural lumbar spinal ultrasonography and skin marking. Spinal anesthesia will be administered with injection of intrathecal bupivacaine and intrathecal fentanyl.

Treatment:

Drug: Intrathecal Fentanyl

Procedure: Spinal Anesthesia

Drug: Intrathecal Bupivacaine

Radiation: Lumbar Spinal Ultrasonography

Palpation

Active Comparator group

Description:

Sham ultrasound procedure. Conventional landmark palpation and skin marking.Spinal anesthesia will be administered with injection of intrathecal bupivacaine and intrathecal fentanyl.

Treatment:

Radiation: Sham Ultrasound Procedure

Drug: Intrathecal Fentanyl

Procedure: Spinal Anesthesia

Drug: Intrathecal Bupivacaine

Procedure: Conventional Landmark Palpation