Anesthesia, Spinal, Ultrasonography
Conditions
Brief summary
Ultrasound has emerged as an useful tool for neuraxial blockade. The aim of this study is to compare the efficacy and safety between the midline approach and paramedian approach for ultrasound-assisted spinal anesthesia in adult patients.
Interventions
PROCEDUREultrasound-assisted midline approach
A preprocedural ultrasound scanning will be done, and skin marking will be made. The needle entry point and insertion angle will be determined based on ultrasound scanning. Spinal anesthesia will be performed via midline approach.
PROCEDUREultrasound-assisted paramedian approach
A preprocedural ultrasound scanning will be done, and skin marking will be made. The needle entry point and insertion angle will be determined based on ultrasound scanning. Spinal anesthesia will be performed via paramedian approach.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients scheduled to undergoing elective orthopedic surgery under spinal anesthesia, with ASA physical status classification I, II, III
Exclusion criteria
* Patients with contraindication to spinal anesthesia (coagulopathy, local infection, allergy to local anesthetic) * Patients with morbid cardiac diseases * Pregnancy * Patients with previous history of lumbar spinal surgery * Patients with anatomical abnormality of lumbar spine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the number of needle passes | Intraoperative (from the first insertion of needle to patient's skin, until the completion of spinal anesthetic injection) | the number of forward advancements of the spinal needle in a given interspinous space, i.e., withdrawal and redirection of spinal needle without exiting the skin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time for identifying landmarks | intraoperative (time taken for establish the landmark, from start of US scanning to completion of scanning | time from placement of the ultrasound probe on the skin to the completion of markings. |
| Time taken for performing spinal anesthetic | Intraoperative (from insertion of the needle to the completion of injection) | time from needle insertion to the completion of injection |
| dermatome level of sensory block | 20 minutes after the completion of spinal anesthetic injection | thoracic dermatome level of sensory block assessed by loss of cold sensation tested with 2% chlorhexidine swab |
| Number of spinal needle insertion attempts | Intraoperative (from the first insertion of needle to patient's skin, until the completion of spinal anesthetic injection) | the number of times the spinal needle was withdrawn from the skin and reinserted |
| Periprocedural pain | Patients will be asked immediately after the completion of spinal anesthesia | 11-point verbal rating scale (0=no pain, 10=most pain imaginable) |
| Periprocedural discomfort score | Patients will be asked immediately after the completion of spinal anesthesia | 11-point verbal rating scale (0=no discomfort, 10=most discomfort imaginable) |
| Patient satisfaction score of spinal anesthesia procedure | Patients will be asked immediately after the completion of spinal anesthesia | 11-point verbal rating scale (0=very unsatisfied, 10=very satisfied) |
| Incidence of radicular pain, paraesthesia, and blood tapping in the spinal needle | Intraoperative (from the first insertion of needle, until the completion of spinal anesthetic injection) | Incidence of radicular pain, paraesthesia, and blood tapping in the spinal needle during the spinal anesthesia procedure |
Countries
South Korea
Outcome results
None listed