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

K

Kafrelsheikh University

Status

Enrolling

Conditions

Spinal Anesthesia
Ultrasound Assistance
Obesity, Morbid

Treatments

Procedure: Ultrasound assistance paramedian spinal group
Procedure: Paramedian conventional palpation group

Study type

Interventional

Funder types

Other

Identifiers

NCT05240846
MKSU 48-1-31

Details and patient eligibility

About

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.

Full 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.

Enrollment

64 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

64 participants in 2 patient groups

Paramedian conventional palpation group
Experimental group
Description:
Patients in this group underwent conventional landmark guided paramedian spinal anesthetic. The spinal anesthesia will be administered based on conventional landmark-based paramedian approach.
Treatment:
Procedure: Paramedian conventional palpation group
Ultrasound assistance paramedian spinal group
Experimental group
Description:
This group will have their spinal anesthetic done based on Ultrasound assistance paramedian spinal.
Treatment:
Procedure: Ultrasound assistance paramedian spinal group

Trial contacts and locations

1

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Central trial contact

Mohammad Algyar, MD

Data sourced from clinicaltrials.gov

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