Clinical trial NCT03792191: Ultrasonography Versus Palpation for Spinal Anesthesia in Obese Parturients Undergoing Cesarean Delivery
Official title: Ultrasonography Versus Palpation for Spinal Anesthesia in Obese Parturients Undergoing Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Spinal
Cesarean Section
Spinal Ultrasound
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2019-01-03
Enrollment: 280
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Needle Passes Required to Obtain Free Cerebrospinal Fluid Flow
timeFrame: Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes
Secondary outcomes:
measure: Number of Skin Punctures Required to Obtain Free Cerebrospinal Fluid Flow
timeFrame: Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes
measure: Rate of Successful Obtaining of Free Cerebrospinal Fluid Flow at the First Needle Pass
timeFrame: Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes
measure: Rate of Successful Obtaining of Free Cerebrospinal Fluid Flow at the First Skin Puncture
timeFrame: Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes
measure: Duration of the Spinal Procedure
timeFrame: Assessed from enrollment in the study until completion of cesarean delivery
measure: Patient Satisfaction
timeFrame: Assessed at 1 minute after intrathecal injection
measure: Number of Participants With Vascular Puncture
timeFrame: Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes
measure: Number of Participants With Paresthesia
timeFrame: Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes
measure: Number of Participants With Failure to Obtain Free Cerebrospinal Fluid Flow
timeFrame: Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes
measure: Number of Participants With Failed Spinal Block
timeFrame: Assessed up to 20 minutes after intrathecal injection
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Department of Anesthesia, Mansoura University Hospitals
state: Dakahlia
Study officials:
affiliation: Mansoura University Hospital
name: Mohamed M Tawfik, MD
role: STUDY_DIRECTOR
affiliation: Mansoura University Hospital
name: Mohamed A Tolba, MSc
role: PRINCIPAL_INVESTIGATOR
References: