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

NCT03792191 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2021-05-24

Study results available
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Summary

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

Conditions

  • Anesthesia, Spinal
  • Cesarean Section
  • Spinal Ultrasound

Interventions

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

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Mohamed M Tawfik, MD · Mansoura University Hospital

  • Mohamed A Tolba, MSc · Mansoura University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-16
Primary Completion
2021-01-31
Completion
2021-01-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03792191 on ClinicalTrials.gov