Skip to content

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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05240846
Enrollment
64
Registered
2022-02-15
Start date
2022-02-23
Completion date
2023-09-20
Last updated
2023-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Morbid, Spinal Anesthesia, Ultrasound Assistance

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.

Interventions

PROCEDUREParamedian 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.

PROCEDUREUltrasound 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.

Sponsors

Kafrelsheikh University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
The rate of successful dural puncture on the first attemptIntraoperativelyFirst-attempt success rate will be recorded

Secondary

MeasureTime frameDescription
Total success rate of spinal anesthesiaIntraoperativelySuccessful Dural Puncture Rates for Selected Number of Attempts and Passes in both intervention groups
Adverse reactions during punctureIntraoperativelyAdverse reactions during puncture as incidence of nerve stimulation
Complications after anesthesia24 hours PostoperativeComplications after anesthesia as incidence of low back pain
Patients' satisfaction after surgery24 hours Postoperative6- Degree of patient satisfaction will be assessed on a 3-point scale; (1= unsatisfied 2= neither satisfied nor unsatisfied 3= satisfied)

Countries

Egypt

Contacts

Primary ContactMohammad Algyar, MD
mohammad.algaiar@med.kfs.edu.eg0111645345

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026