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

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

Study Overview

• Status: Completed
• Conditions: Cesarean Section; Anesthesia, Spinal; Spinal Ultrasound
• Intervention / Treatment: Radiation: Lumbar Spinal Ultrasonography; Procedure: Spinal Anesthesia; Drug: Intrathecal Bupivacaine; Drug: Intrathecal Fentanyl; Radiation: Sham Ultrasound Procedure; Procedure: Conventional Landmark Palpation

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.

• Study Type: Interventional
• Enrollment (Actual): 280
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansoura, Dakahlia, Egypt, 35511
      • Department of Anesthesia, Mansoura University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultrasonography; Preprocedural lumbar spinal ultrasonography and skin marking. Spinal anesthesia will be administered with injection of intrathecal bupivacaine and intrathecal fentanyl.	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.; Procedure: 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; Drug: Intrathecal Fentanyl; Fentanyl 15 μg will be administered in the subarachnoid space
Active Comparator: Palpation; Sham ultrasound procedure. Conventional landmark palpation and skin marking.Spinal anesthesia will be administered with injection of intrathecal bupivacaine and intrathecal fentanyl.	Procedure: 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; Drug: Intrathecal Fentanyl; Fentanyl 15 μg will be administered in the subarachnoid space; Radiation: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Director: Mohamed M Tawfik, MD, Mansoura University Hospital; Principal Investigator: Mohamed A Tolba, MSc, Mansoura University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2019
• Primary Completion (Actual): January 31, 2021
• Study Completion (Actual): January 31, 2021

Study Registration Dates

• First Submitted: January 1, 2019
• First Submitted That Met QC Criteria: January 1, 2019
• First Posted (Actual): January 3, 2019

Study Record Updates

• Last Update Posted (Actual): May 24, 2021
• Last Update Submitted That Met QC Criteria: May 20, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Fentanyl; Bupivacaine
• Other Study ID Numbers: MD.18.02.29

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No