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

Not Applicable

Recruiting

• Conditions: Spinal Anesthesia; Ultrasound Assistance; Obesity, Morbid
• Interventions: Procedure: Paramedian conventional palpation group; Procedure: Ultrasound assistance paramedian spinal group

• Registration Number: NCT05240846
• Lead Sponsor: Kafrelsheikh University

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.

Study Timeline

• Study First Submitted: 2022-02-04
• Study First Submitted QC: 2022-02-04
• Study First Posted: 2022-02-15
• Study Start: 2022-02-23
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-03
• Last Update Posted: 2023-09-06
• Primary Completion: 2023-09-20
• Study Completion: 2023-09-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paramedian conventional palpation group	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	Ultrasound assistance paramedian spinal group	This group will have their spinal anesthetic done based on Ultrasound assistance paramedian spinal.

Primary Outcome Measures

Name	Time	Method
The rate of successful dural puncture on the first attempt	Intraoperatively	First-attempt success rate will be recorded

Secondary Outcome Measures

Name	Time	Method
Patients' satisfaction after surgery	24 hours Postoperative	6- Degree of patient satisfaction will be assessed on a 3-point scale; (1= unsatisfied 2= neither satisfied nor unsatisfied 3= satisfied)
Complications after anesthesia	24 hours Postoperative	Complications after anesthesia as incidence of low back pain
Total success rate of spinal anesthesia	Intraoperatively	Successful Dural Puncture Rates for Selected Number of Attempts and Passes in both intervention groups
Adverse reactions during puncture	Intraoperatively	Adverse reactions during puncture as incidence of nerve stimulation

Trial Locations

Locations (1)

Kafr El-Sheikh University Hospitals; 🇪🇬 Kafr Ash Shaykh, Egypt