Spinal Anesthesia Using Ultrasound Assistance Versus Conventional Palpation in Morbidly Obese Patients

Obesity, Morbid Clinical Trial

Official title:

Paramedian Approach for Spinal Anesthesia Using Ultrasound Assistance Versus Conventional Palpation in Morbidly Obese Patients: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05240846
• Other study ID #: MKSU 48-1-31
• Status: Recruiting
• Phase: N/A
• Start date: February 23, 2022
• Est. completion date: September 20, 2023

Study information

• Verified date: September 2023
• Source: Kafrelsheikh University
• Contact: Mohammad Algyar, MD
• Phone: 0111645345
• Email: mohammad.algaiar[@]med.kfs.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare the paramedian approach for spinal anesthesia using ultrasound assistance (USAS) versus conventional palpation in morbidly obese patients undergoing elective surgeries.

Description:

Performing spinal anesthesia using a conventional approach can be considerably challenging in obese patients. Multiple needle attempts may lead to a higher incidence of complications (e.g., postdural puncture headache, paresthesia, hematoma, and infection) and increase patient discomfort and dissatisfaction. Therefore, novel techniques are needed to improve the success rate of spinal anesthesia for such patients. There are two puncture approaches for spinal anesthesia: median approach puncture and paramedian approach puncture. Early studies have noted that the success rate of paramedian approach puncture was higher than that of median approach puncture and that it is associated with fewer complications and postoperative complications. A paramedian approach has been shown to improve the success rate of spinal anesthesia, especially in patients who are unable to sit up or those with a degenerative spine condition. The use of ultrasound has been suggested to increase the efficacy of spinal anesthesia. Recently, ultrasound has emerged as a way to facilitate lumbar neuraxial blocks, namely, the ultrasound assistance (USAS) technique. The ultrasound assistance technique is beneficial for lumbar neuraxial anesthesia, improving technique performance by providing reliable anatomical information.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: September 20, 2023
• Est. primary completion date: September 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age = 18 years
• Both sexes
• Body mass index (BMI) = 40 kg/m2
• Patients undergoing elective surgeries

Exclusion Criteria:

• Rejection of spinal anesthesia
• History of spinal deformity or spinal surgery
• Contraindications to spinal anesthesia (infection of the puncture site, coagulation dysfunction, allergy to local anesthesia, insufficient blood volume or abnormal spinal anatomy).

Related Conditions & MeSH terms

• Obesity, Morbid
• Spinal Anesthesia

Intervention

Procedure:
• Paramedian conventional palpation group
Patients in this group underwent conventional landmark guided paramedian spinal anesthetic. The spinal anesthesia will be administered based on conventional landmark-based paramedian approach.
• Ultrasound assistance paramedian spinal group
This group will have their spinal anesthetic done based on ultrasound assistance paramedian spinal. Spinal anesthesia with a paramedian approach was performed based on the optimum puncture point, suggested puncture angles, and puncture depth. The suggested puncture angles included the cephalad angle measured by the built-in angle program of the ultrasound and the medial angle measured by a 180° protractor (Deli). The puncture depth, the distance from the skin to the posterior complex, was measured utilizing the ultrasound clipper tool.

Locations

Country	Name	City	State
Egypt	Kafr El-Sheikh University Hospitals	Kafr Ash Shaykh

Sponsors (1)

Lead Sponsor	Collaborator
Kafrelsheikh University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of successful dural puncture on the first attempt	First-attempt success rate will be recorded	Intraoperatively
Secondary	Total success rate of spinal anesthesia	Successful Dural Puncture Rates for Selected Number of Attempts and Passes in both intervention groups	Intraoperatively
Secondary	Adverse reactions during puncture	Adverse reactions during puncture as incidence of nerve stimulation	Intraoperatively
Secondary	Complications after anesthesia	Complications after anesthesia as incidence of low back pain	24 hours Postoperative
Secondary	Patients' satisfaction after surgery	6- Degree of patient satisfaction will be assessed on a 3-point scale; (1= unsatisfied 2= neither satisfied nor unsatisfied 3= satisfied)	24 hours Postoperative