The Ultrasound Guided Versus Land-mark Location Method for Performing Spinal Anesthesia in Obese Parturients

Comparison of Ultrasound and Anatomical Land-mark Method in Spinal Anesthesia for Elective Cesarean Section in Obese Parturients With BMI ≥ 40 kg/m2. A Randomized Controlled Trial

This study will be investigated whether an ultrasound-assisted technique is better than a classical land-mark technique to facilitate spinal anesthesia in the lateral position in morbidly obese pregnant women with BMI ≥ 40 who will undergo elective cesarean section.

The primary objective in this study is the rate of successful dural puncture at the first attempt. It was assumed that ultrasound could facilitate neuraxial blockade in grade 3 morbidly obese pregnant women according to the Who classification, whose topographic anatomy is difficult.

Study Overview

• Status: Completed
• Conditions: Morbid Obesity
• Intervention / Treatment: Procedure: Ultrasound group; Procedure: Landmark group

Detailed Description

Spinal anesthesia is the most commonly used anesthesia method for elective cesarean deliveries. Anesthesiologists may have difficulties in determining the poorly palpable surface landmarks in morbidly obese pregnant women.

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

This study will be conducted as 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. Patient, 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 150 ultrasound-guided neuraxial blocks.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Karaman, Turkey, 70200
    • Karaman Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Parturient who will receive selective cesarean delivery under spinal anesthesia
• ASA 2-3 scheduled for elective sections
• BMI≥40 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<40 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: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ultrasound group; Ultrasound assited technique will be used for spinal anesthesia performance.	Procedure: Ultrasound 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 group; Land-mark assisted technique will be used for spinal anesthesia performance.	Procedure: Landmark 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 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
Patient satisfaction The procedure duration	Patients rated their satisfaction as very satisfied, satisfied, or dissatisfied immediately after the procedure.	30 minute
incidence of complications during puncture	Incidence of radicular pain, paresthesia, and blood during spinal needle injection	30 minute
incidence of postoperative headache	12-72 hours following spinal anesthesia due to CSF leakage	72 hour
Incidence of hypotension	A systolic arterial pressure decrease of more than 25% from baseline or less than 90 mmHg	2 hour
Failure rate of spinal anesthesia	Number of parturients who need additional analgesic drug or conversion to general anesthesia	120 minute
dermatome level of sensory block [ Time Frame: 10 minutes after spinal anesthetic injection ]	thoracic dermatome level of sensory block assessed by pinprick test	20 minute

Collaborators and Investigators

• Sponsor: Karaman Training and Research Hospital
• Investigators: Study Director: Betül Başaran, MD,DESA, Karaman Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2022
• Primary Completion (Actual): January 23, 2023
• Study Completion (Actual): January 24, 2023

Study Registration Dates

• First Submitted: April 18, 2022
• First Submitted That Met QC Criteria: April 18, 2022
• First Posted (Actual): April 25, 2022

Study Record Updates

• Last Update Posted (Estimate): January 25, 2023
• Last Update Submitted That Met QC Criteria: January 24, 2023
• Last Verified: April 1, 2022

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: 02-2022/02

Drug and device information, study documents

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