Clinical trial NCT03316352: Ultrasound-assisted Versus Conventional Landmark-guided Paramedian Spinal Anesthesia in Elderly Patients
Official title: Ultrasound-assisted Versus Conventional Landmark-guided Paramedian Spinal Anesthesia in Elderly Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Spinal
Ultrasonography
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-10-20
Enrollment: 80
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: the number of needle passes
timeFrame: from the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection
Secondary outcomes:
measure: Number of spinal needle insertion attempts
timeFrame: from the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection
measure: Time for identifying landmarks
timeFrame: from the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection
measure: Time taken for performing spinal anesthetic
timeFrame: from the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection
measure: Level of block
timeFrame: 5, 10, 15 minutes after the completion of spinal anesthetic injection
measure: Incidence of radicular pain, paraesthesia, and blood tapping in the spinal needle
timeFrame: from the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection
measure: Periprocedural pain
timeFrame: from the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection
measure: Periprocedural discomfort score
timeFrame: from the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jin-Tae Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kallidaikurichi Srinivasan K, Iohom G, Loughnane F, Lee PJ. Conventional Landmark-Guided Midline Versus Preprocedure Ultrasound-Guided Paramedian Techniques in Spinal Anesthesia. Anesth Analg. 2015 Oct;121(4):1089-1096. doi: 10.1213/ANE.0000000000000911.
citation: Chin KJ, Perlas A, Chan V, Brown-Shreves D, Koshkin A, Vaishnav V. Ultrasound imaging facilitates spinal anesthesia in adults with difficult surface anatomic landmarks. Anesthesiology. 2011 Jul;115(1):94-101. doi: 10.1097/ALN.0b013e31821a8ad4.
citation: Park SK, Yoo S, Kim WH, Lim YJ, Bahk JH, Kim JT. Ultrasound-assisted vs. landmark-guided paramedian spinal anaesthesia in the elderly: A randomised controlled trial. Eur J Anaesthesiol. 2019 Oct;36(10):763-771. doi: 10.1097/EJA.0000000000001029.