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Clinical Trials/NCT05240846
NCT05240846
Recruiting
Not Applicable

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

Kafrelsheikh University1 site in 1 country64 target enrollmentFebruary 23, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spinal Anesthesia
Sponsor
Kafrelsheikh University
Enrollment
64
Locations
1
Primary Endpoint
The rate of successful dural puncture on the first attempt
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 23, 2022
End Date
September 20, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohamed Fouad Algyar

Doctor

Kafrelsheikh University

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).

Outcomes

Primary Outcomes

The rate of successful dural puncture on the first attempt

Time Frame: Intraoperatively

First-attempt success rate will be recorded

Secondary Outcomes

  • Patients' satisfaction after surgery(24 hours Postoperative)
  • Complications after anesthesia(24 hours Postoperative)
  • Total success rate of spinal anesthesia(Intraoperatively)
  • Adverse reactions during puncture(Intraoperatively)

Study Sites (1)

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