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

Obesity, Morbid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06410820
• Other study ID #: 11-2022/03
• Status: Recruiting
• Phase: N/A
• Start date: May 16, 2024
• Est. completion date: October 2, 2024

Study information

• Verified date: April 2024
• Source: Karaman Training and Research Hospital
• Contact: Betul Basaran, MD,DESA
• Phone: +903382263000
• Email: betulbasaran1[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Obesity, Morbid

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Karaman Training and Research Hospital	Karaman

Sponsors (1)

Lead Sponsor	Collaborator
Karaman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

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