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

Study Overview
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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

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.

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

Conditions
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Anesthesia, Spinal, Cesarean Section, Spinal Ultrasound

Intervention / Treatment
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* Radiation: Lumbar Spinal Ultrasonography
* Radiation: Sham Ultrasound Procedure
* Procedure: Conventional Landmark Palpation
* Procedure: Spinal Anesthesia
* Drug: Intrathecal Bupivacaine
* Drug: Intrathecal Fentanyl


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasonography<br>Preprocedural lumbar spinal ultrasonography and skin marking. Spinal anesthesia will be administered with injection of intrathecal bupivacaine and intrathecal fentanyl. | Radiation: Lumbar Spinal Ultrasonography<br>* 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.<br>Procedure: Spinal Anesthesia<br>* Spinal anesthesia using a 25- or 22-gauge spinal needle<br>Drug: Intrathecal Bupivacaine<br>* Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space<br>Drug: Intrathecal Fentanyl<br>* Fentanyl 15 μg will be administered in the subarachnoid space<br>|
| Active Comparator: Palpation<br>Sham ultrasound procedure. Conventional landmark palpation and skin marking.Spinal anesthesia will be administered with injection of intrathecal bupivacaine and intrathecal fentanyl. | Radiation: Sham Ultrasound Procedure<br>* Moving the ultrasound probe on the patient's back with the machine in the freeze position.<br>Procedure: Conventional Landmark Palpation<br>* 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.<br>Procedure: Spinal Anesthesia<br>* Spinal anesthesia using a 25- or 22-gauge spinal needle<br>Drug: Intrathecal Bupivacaine<br>* Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space<br>Drug: Intrathecal Fentanyl<br>* Fentanyl 15 μg will be administered in the subarachnoid space<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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