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

M

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

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

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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