Midline Versus Paramedian Approaches for Ultrasound-assisted Spinal Anesthesia: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 112
- Locations
- 1
- Primary Endpoint
- the number of needle passes
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Midline group
Preprocedural ultrasound-assisted midline approach of spinal anesthesia will be performed. 0.5% heavy bupivacaine will be injected to intrathecal space for spinal anesthesia.
Intervention: ultrasound-assisted midline approach (Procedure)
Paramedian group
Preprocedural ultrasound-assisted paramedian approach of spinal anesthesia will be performed. 0.5% heavy bupivacaine will be injected to intrathecal space for spinal anesthesia.
Intervention: ultrasound-assisted paramedian approach (Procedure)
Outcomes
Primary Outcomes
the number of needle passes
Time Frame: 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 Outcomes
- 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))
- Number of spinal needle insertion attempts(Intraoperative (from the first insertion of needle to patient's skin, until the completion of spinal anesthetic injection))
- Time for identifying landmarks(intraoperative (time taken for establish the landmark, from start of US scanning to completion of scanning)
- Time taken for performing spinal anesthetic(Intraoperative (from insertion of the needle to the completion of injection))
- dermatome level of sensory block(20 minutes after the completion of spinal anesthetic injection)
- Periprocedural pain(Patients will be asked immediately after the completion of spinal anesthesia)
- Periprocedural discomfort score(Patients will be asked immediately after the completion of spinal anesthesia)
- Patient satisfaction score of spinal anesthesia procedure(Patients will be asked immediately after the completion of spinal anesthesia)
Investigators
Jin-Tae Kim
Professor
Seoul National University Hospital