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Ultrasound-assisted Versus Conventional Landmark-guided Spinal Anesthesia in Patients With Abnormal Spinal Anatomy

Ultrasound-assisted Versus Conventional Landmark-guided Spinal Anesthesia in Patients With Abnormal Spinal Anatomy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03459105
Enrollment
44
Registered
2018-03-08
Start date
2018-03-13
Completion date
2018-07-05
Last updated
2019-01-03

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

Conditions

Anesthesia, Spinal, Scoliosis, Ultrasonography

Brief summary

Spinal anesthesia can be challenging in patients with lumbar scoliosis or previous lumbar spine surgery. This study aims to evaluate whether the use of the ultrasound-assisted spinal anesthesia reduces the number of passes required to successful dural puncture compared with the conventional surface landmark-guided technique in patients with abnormal spinal anatomy.

Interventions

PROCEDUREUltrasound-assisted paramedian spinal anesthesia

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.

Spinal anesthesia will be done using conventional landmark-guided technique.

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
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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, * and with (1) or (2) 1. documented scoliosis in preoperative L-S-Spine X-ray (Cobb abgle \> 10 degree) 2. previous history of lumbar spinal surgery

Exclusion criteria

* Patients with contraindication to spinal anesthesia (coagulopathy, local infection, allergy to local anesthetic) * Patients with morbid cardiac diseases * Pregnancy

Design outcomes

Primary

MeasureTime frameDescription
the number of needle passesIntraoperative (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

MeasureTime frameDescription
Time for identifying landmarks1 day (time taken for establish the landmark, from start of palpation/US scanning to completion of palpation/scanning)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 anestheticIntraoperative (from insertion of the needle to the completion of injection)time from needle insertion to the completion of injection
dermatome level of sensory block5, 10, 15 minutes after the completion of spinal anesthetic injectionthoracic dermatome level of sensory block assessed by loss of cold sensation tested with 2% chlorhexidine swab
Number of spinal needle insertion attemptsIntraoperative (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 painPatients will be asked immediately after the completion of spinal anesthesia11-point verbal rating scale (0=no pain, 10=most pain imaginable)
Periprocedural discomfort scorePatients will be asked immediately after the completion of spinal anesthesia11-point verbal rating scale (0=no discomfort, 10=most discomfort imaginable)
Incidence of radicular pain, paraesthesia, and blood tapping in the spinal needleIntraoperative (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

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