Clinical trial NCT03459105: Ultrasound-assisted Versus Conventional Landmark-guided Spinal Anesthesia in Patients With Abnormal Spinal Anatomy
Official title: Ultrasound-assisted Versus Conventional Landmark-guided Spinal Anesthesia in Patients With Abnormal Spinal Anatomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Spinal
Ultrasonography
Scoliosis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-03-08
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: the number of needle passes
timeFrame: Intraoperative (from the first insertion of needle to patient's skin, until the completion of spinal anesthetic injection)
Secondary outcomes:
measure: Number of spinal needle insertion attempts
timeFrame: Intraoperative (from the first insertion of needle to patient's skin, until the completion of spinal anesthetic injection)
measure: Time for identifying landmarks
timeFrame: 1 day (time taken for establish the landmark, from start of palpation/US scanning to completion of palpation/scanning)
measure: Time taken for performing spinal anesthetic
timeFrame: Intraoperative (from insertion of the needle to the completion of injection)
measure: dermatome level of sensory 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: Intraoperative (from the first insertion of needle, until the completion of spinal anesthetic injection)
measure: Periprocedural pain
timeFrame: Patients will be asked immediately after the completion of spinal anesthesia
measure: Periprocedural discomfort score
timeFrame: Patients will be asked immediately after the completion of spinal anesthesia
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: 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.