Clinical trial NCT05240846: Spinal Anesthesia Using Ultrasound Assistance Versus Conventional Palpation in Morbidly Obese Patients
Official title: Paramedian Approach for Spinal Anesthesia Using Ultrasound Assistance Versus Conventional Palpation in Morbidly Obese Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Anesthesia
Ultrasound Assistance
Obesity, Morbid
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2022-02-15
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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).

Primary outcomes:
measure: The rate of successful dural puncture on the first attempt
timeFrame: Intraoperatively
Secondary outcomes:
measure: Total success rate of spinal anesthesia
timeFrame: Intraoperatively
measure: Adverse reactions during puncture
timeFrame: Intraoperatively
measure: Complications after anesthesia
timeFrame: 24 hours Postoperative
measure: Patients' satisfaction after surgery
timeFrame: 24 hours Postoperative
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Kafr El-Sheikh University Hospitals
Study officials:
References: