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

Not Applicable

Completed

• Conditions: Anesthesia, Spinal; Spinal Ultrasound; Cesarean Section
• Interventions: Radiation: Lumbar Spinal Ultrasonography; Radiation: Sham Ultrasound Procedure; Procedure: Spinal Anesthesia; Procedure: Conventional Landmark Palpation; Drug: Intrathecal Bupivacaine; Drug: Intrathecal Fentanyl

• Registration Number: NCT03792191
• Lead Sponsor: Mansoura University

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-01-01
• Study First Submitted QC: 2019-01-01
• Study First Posted: 2019-01-03
• Study Start: 2019-01-16
• Primary Completion: 2021-01-31
• Study Completion: 2021-01-31
• Results First Submitted: 2021-04-23
• Status Verified: 2021-05
• Results First Submitted QC: 2021-05-20
• Last Update Submitted: 2021-05-20
• Results First Posted: 2021-05-24
• Last Update Posted: 2021-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 280

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasonography	Spinal Anesthesia	Preprocedural lumbar spinal ultrasonography and skin marking. Spinal anesthesia will be administered with injection of intrathecal bupivacaine and intrathecal fentanyl.
Ultrasonography	Intrathecal Bupivacaine	Preprocedural lumbar spinal ultrasonography and skin marking. Spinal anesthesia will be administered with injection of intrathecal bupivacaine and intrathecal fentanyl.
Palpation	Intrathecal Bupivacaine	Sham ultrasound procedure. Conventional landmark palpation and skin marking.Spinal anesthesia will be administered with injection of intrathecal bupivacaine and intrathecal fentanyl.
Ultrasonography	Lumbar Spinal Ultrasonography	Preprocedural lumbar spinal ultrasonography and skin marking. Spinal anesthesia will be administered with injection of intrathecal bupivacaine and intrathecal fentanyl.
Ultrasonography	Intrathecal Fentanyl	Preprocedural lumbar spinal ultrasonography and skin marking. Spinal anesthesia will be administered with injection of intrathecal bupivacaine and intrathecal fentanyl.
Palpation	Sham Ultrasound Procedure	Sham ultrasound procedure. Conventional landmark palpation and skin marking.Spinal anesthesia will be administered with injection of intrathecal bupivacaine and intrathecal fentanyl.
Palpation	Conventional Landmark Palpation	Sham ultrasound procedure. Conventional landmark palpation and skin marking.Spinal anesthesia will be administered with injection of intrathecal bupivacaine and intrathecal fentanyl.
Palpation	Spinal Anesthesia	Sham ultrasound procedure. Conventional landmark palpation and skin marking.Spinal anesthesia will be administered with injection of intrathecal bupivacaine and intrathecal fentanyl.
Palpation	Intrathecal Fentanyl	Sham ultrasound procedure. Conventional landmark palpation and skin marking.Spinal anesthesia will be administered with injection of intrathecal bupivacaine and intrathecal fentanyl.

Primary Outcome Measures

Name	Time	Method
Number of Needle Passes Required to Obtain Free Cerebrospinal Fluid Flow	Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes	Needle pass is any forward introduction of the spinal needle after its complete or incomplete withdrawal, including the first attempt.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Paresthesia	Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes	Number of participants with paresthesia reported by the subjects during performing the spinal procedure
Number of Participants With Failure to Obtain Free Cerebrospinal Fluid Flow	Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes	Number of participants with failure to obtain free cerebrospinal fluid flow after adequate needle passes at 6 separate skin punctures.
Rate of Successful Obtaining of Free Cerebrospinal Fluid Flow at the First Skin Puncture	Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes	Skin puncture is any separate skin puncture by the spinal needle after its complete withdrawal, including the first attempt.
Rate of Successful Obtaining of Free Cerebrospinal Fluid Flow at the First Needle Pass	Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes	Needle pass is any forward introduction of the spinal needle after its complete or incomplete withdrawal, including the first attempt.
Number of Participants With Vascular Puncture	Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes	Number of participants with unintentional vascular puncture by the needle during performing the spinal procedure
Number of Skin Punctures Required to Obtain Free Cerebrospinal Fluid Flow	Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes	Skin puncture is any separate skin puncture by the spinal needle after its complete withdrawal, including the first attempt.
Patient Satisfaction	Assessed at 1 minute after intrathecal injection	Patient satisfaction from the procedure assessed immediately after intrathecal injection using a 5-point scale (1 = very unsatisfied; 2 = unsatisfied; 3 = fair; 4 = satisfied; and 5 = very satisfied).
Number of Participants With Failed Spinal Block	Assessed up to 20 minutes after intrathecal injection	Number of participants with failed spinal block defined as an upper sensory level below T6 assessed by pinprick.
Duration of the Spinal Procedure	Assessed from enrollment in the study until completion of cesarean delivery	The duration from starting the first skin puncture by the spinal needle to obtaining free CSF flow

Trial Locations

Locations (1)

Department of Anesthesia, Mansoura University Hospitals; 🇪🇬 Mansoura, Dakahlia, Egypt