Ultrasound Guided Versus Land-mark Method for Spinal Anesthesia in Super Obesity Parturients

Comparison of Ultrasound and Anatomical Landmark Method in Spinal Anesthesia for Elective Cesarean Section in Super Obese Parturients With BMI ≥ 50 kg/m2. A Randomized Controlled Trial

This study will investigate whether an ultrasound-assisted technique is better than a classical land-mark technique to facilitate spinal anesthesia in the sitting position in super obese pregnant women with BMI ≥ 50 who will undergo elective cesarean section.

The primary objective of this study is the rate of successful dural puncture at the first attempt. It was assumed that ultrasound could facilitate neuraxial blockade in super obese (BMI ≥ 50 kg/m2), pregnant women, according to the Who classification, whose topographic anatomy is difficult.

Study Overview

• Status: Recruiting
• Conditions: Obesity, Morbid
• Intervention / Treatment: Device: Procedure/Surgery: Ultrasound method group; Device: Landmark method group

Detailed Description

Spinal anesthesia is the most commonly used anesthesia method for elective cesarean deliveries. Anesthesiologists may struggle to determine the poorly palpable surface landmarks in super obese (BMI ≥ 50 kg/m2) pregnant women.

The manual palpation technique, preferred in neuraxial anesthesia, may be very difficult in super obese pregnant women due to difficulty identifying bone landmarks. Neuraxial ultrasound examination before spinal anesthesia may help spinal anesthesia performance and decrease the number of attempts in obese parturients.

This study will be a single-center, prospective, randomized, double-blinded trial in a university hospital. Patients scheduled for elective cesarean will be screened for enrollment in the study. The anesthetist administering spinal anesthesia and evaluating the data were blind to the distribution of patient groups. Ultrasonographic examinations were performed by a single investigator trained in this technique who performed more than 60 ultrasound-guided neuraxial blocks.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Betul Basaran, MD,DESA; Phone Number: +903382263000; Email: betulbasaran1@yahoo.com

Study Locations

• Turkey
  • Karaman, Turkey, 70200
    • Recruiting
    • Karaman Training and Research Hospital
    • Contact: Betul Basaran, MD,DESA; Phone Number: +90 338 226 33 20; Email: betulbasaran1@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Parturient who will receive selective cesarean delivery under spinal anesthesia
• ASA 3 scheduled for elective sections
• BMI≥50 kg/m2

• Normal singleton pregnancy

  • 37 weeks of gestation

Exclusion Criteria:

• Multiple gestations
• Emergency C-section
• Exist contraindications of spinal anesthesia
• Local anesthetics allergy
• BMI<50 kg/m2
• History of lumbar spinal diseases and lumbar surgery
• Parturient refusal

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
Active Comparator: Ultrasound method group; The ultrasound-assisted technique will be used for spinal anesthesia performance.	Device: Procedure/Surgery: Ultrasound method group; In the operating room, all of the patients will receive standard monitoring. Scans will be made in logiditunal parasagittal and transverse midline views with ultrasound. Needle entry sites in the L2-L3 and L3-L4 intervals will be determined as the intersection of the longiditunal and transverse lines. When the spinal puncture operator is outside the room, Needle entry sites were marked for both groups.After skin marking, the pregnant woman will be asked to remain still and a subarachnoid puncture will be performed immediately. Spinal anesthesia will be administered with injection of intrathecal bupivacaine.
Experimental: Landmark method group; Land-mark assisted technique will be used for spinal anesthesia performance.	Device: Landmark method group; In the Landmark group, the injection site will be determined using the traditional method of palpating the posterior superior iliac spine.When the spinal puncture operator is outside the room, Needle entry sites were marked for both groups.After skin marking, the pregnant woman will be asked to remain still and a subarachnoid puncture will be performed immediately. Spinal anesthesia will be administered with injection of intrathecal bupivacaine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The success rate of the first puncture	Success on a single-puncture attempt will be defined as reaching the subarachnoid space on the first insertion of the needle.	30 minute

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of skin punctures	Skin puncture is defined as any separate skin puncture attempt.	30 minute
Number of needle pass	Needle pass is defined as skin puncture plus number of redirection attempts	30 minute
The procedure duration time	The duration from initiation of location marking by palpation or ultrasound to obtaining free cerebrospinal fluid flow	30 minute
Time interval to determine needle insertion site	Time interval between the operator touches the parturient and the completion of the needle insertion point marking	30 minute
Time taken for spinal injection	The time interval between the needle insertion to visualization of cerebrospinal spinal fluid in the spinal needle.	30 minute
Number of puncture levels	Move to a second lumbar space after 3 needle insertion attempts	30 minute
Failure rate of spinal anesthesia	Number of parturients who need additional analgesic drug or conversion to general anesthesia	120 minute
Patient satisfaction The procedure duration	Patients rated their satisfaction as very satisfied, satisfied, or dissatisfied immediately after the procedure.	120 minute
incidence of complications during puncture	Incidence of radicular pain, paresthesia, and blood during spinal needle injection	120 minute
incidence of postoperative headache	12-72 hours following spinal anesthesia due to CSF leakage	72 hours
Incidence of hypotension	A systolic arterial pressure decrease of more than 25% from baseline or less than 90 mmHg	2 hours
dermatome level of sensory block	thoracic dermatome level of sensory block assessed by pinprick test	10 minute

Collaborators and Investigators

• Sponsor: Karaman Training and Research Hospital
• Investigators: Principal Investigator: Ayşegül Bilge, MD, Karaman TRH

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2024
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 2, 2024

Study Registration Dates

• First Submitted: April 4, 2024
• First Submitted That Met QC Criteria: May 8, 2024
• First Posted (Actual): May 13, 2024

Study Record Updates

• Last Update Posted (Actual): June 5, 2024
• Last Update Submitted That Met QC Criteria: June 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Ultrasound; Cesarean Delivery; Spinal Anesthesia
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: 11-2022/03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No