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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-16

Study Completion Date

2021-01-31

Brief Summary

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

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Detailed Description

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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

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Anesthesia, Spinal Cesarean Section Spinal Ultrasound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Ultrasonography

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

Group Type EXPERIMENTAL

Lumbar Spinal Ultrasonography

Intervention Type RADIATION

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.

Spinal Anesthesia

Intervention Type PROCEDURE

Spinal anesthesia using a 25- or 22-gauge spinal needle

Intrathecal Bupivacaine

Intervention Type DRUG

Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space

Intrathecal Fentanyl

Intervention Type DRUG

Fentanyl 15 μg will be administered in the subarachnoid space

Palpation

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

Group Type ACTIVE_COMPARATOR

Sham Ultrasound Procedure

Intervention Type RADIATION

Moving the ultrasound probe on the patient's back with the machine in the freeze position.

Conventional Landmark Palpation

Intervention Type PROCEDURE

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.

Spinal Anesthesia

Intervention Type PROCEDURE

Spinal anesthesia using a 25- or 22-gauge spinal needle

Intrathecal Bupivacaine

Intervention Type DRUG

Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space

Intrathecal Fentanyl

Intervention Type DRUG

Fentanyl 15 μg will be administered in the subarachnoid space

Interventions

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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.

Intervention Type RADIATION

Sham Ultrasound Procedure

Moving the ultrasound probe on the patient's back with the machine in the freeze position.

Intervention Type RADIATION

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.

Intervention Type PROCEDURE

Spinal Anesthesia

Spinal anesthesia using a 25- or 22-gauge spinal needle

Intervention Type PROCEDURE

Intrathecal Bupivacaine

Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space

Intervention Type DRUG

Intrathecal Fentanyl

Fentanyl 15 μg will be administered in the subarachnoid space

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No