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

Cesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03792191
• Other study ID #: MD.18.02.29
• Status: Completed
• Phase: N/A
• Start date: January 16, 2019
• Est. completion date: January 31, 2021

Study information

• Verified date: May 2021
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: January 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, Spinal
• Cesarean Section
• Spinal Ultrasound

Intervention

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.
• 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.
• 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
• Intrathecal Fentanyl
Fentanyl 15 µg will be administered in the subarachnoid space

Locations

Country	Name	City	State
Egypt	Department of Anesthesia, Mansoura University Hospitals	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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