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

NCT ID: NCT05240846

Last Updated: 2023-09-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-23
• Study Completion Date: 2023-09-20

Brief 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.

Detailed 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.

Conditions

Spinal Anesthesia; Ultrasound Assistance; Obesity, Morbid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Paramedian conventional palpation group

Intervention Type: PROCEDURE

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.

Group Type: EXPERIMENTAL

Ultrasound assistance paramedian spinal group

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kafrelsheikh University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Fouad Algyar

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kafr El-Sheikh University Hospitals

Kafr ash Shaykh, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mohammad Algyar, MD

Role: CONTACT

mohammad.algaiar@med.kfs.edu.eg

0111645345 ext. +2

Facility Contacts

Mohammad Algyar, MSc.

Role: primary

mohammad.algaiar@med.kfs.edu.eg

Other Identifiers

MKSU 48-1-31

Identifier Type: -

Identifier Source: org_study_id