Anesthesia, Spinal, Ultrasonography
Conditions
Brief summary
Multiple passes and attempts during spinal anesthesia might be associated with a greater incidence of paraesthesia, postdural puncture headache, and spinal hematoma. We hypothesized that the use of a preprocedural ultrasound-assisted paramedian technique for spinal anesthesia in patients with old age would reduce the number of passes required to entry into the subarachnoid space when compared with the landmark-guided paramedian approach. The study participants will be randomized into group L (landmark-guided) and group U (ultrasound-assisted). In group L, spinal anesthesia will be performed via paramedian approach using conventional landmark palpation technique. In group U, a preprocedural ultrasound scan will be used to mark the needle insertion site, and spinal anesthetic will be done via the paramedian approach.
Interventions
PROCEDUREUltrasound-assisted paramedian technique spinal anesthesia
Ultrasound-assisted paramedian technique will be used. A preprocedural ultrasound scan will be performed, and skin marking for spinal entry site will be done using ultrasound scan. Spinal anesthesia will be done according to skin marking using ultrasound, via paramedian approach.
PROCEDURELandmark-guided paramedian technique spinal anesthesia
Landmark-guided paramedian technique will be used. Spinal anesthesia will be done using conventional landmark-guided paramedian technique.
DEVICEUltrasound
A preprocedural ultrasound scan will be done using Portable Echocardiography system (Vivid-i, GE healthcare) with 4C-RS convex probe (2.0-5.5 MHz Frequency range).
During spinal anesthesia, 0.5% heavy bupivacaine will be administered into intrathecal space. The dose of local anesthetic injected for spinal anesthesia will be at the discretion of the attending anesthesiologist. The dose range of intrathecal bupivacaine will be between 12 and 16 mg.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Elderly patients (age≥60 years) scheduled to undergoing elective orthopedic surgery under spinal anesthesia * Patients 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 spine surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the number of needle passes | from the initiation of spinal anesthesia procedure, 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 | from the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection | In group L, time from start of palpation to completion of the process, as declared by the anesthesiologist. In group U, time from placement of the ultrasound probe on the skin to the completion of markings. |
| Time taken for performing spinal anesthetic | from the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection | time from needle insertion to the completion of injection |
| Level of block | 5, 10, 15 minutes after the completion of spinal anesthetic injection | loss of cold sensation tested with 2% chlorhexidine swab |
| Number of spinal needle insertion attempts | from the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection | the number of times the spinal needle was withdrawn from the skin and reinserted |
| Periprocedural pain | from the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection | 11-point verbal rating scale (0=no pain, 10=most pain imaginable) |
| Periprocedural discomfort score | from the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection | 11-point verbal rating scale (0=no discomfort, 10=most discomfort imaginable) |
| Incidence of radicular pain, paraesthesia, and blood tapping in the spinal needle | from the initiation of spinal anesthesia procedure, 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