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

Primary Purpose

Anesthesia, Spinal, Ultrasonography, Scoliosis

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ultrasound-assisted paramedian spinal anesthesia
Landmark-guided spinal anesthesia
0.5% heavy bupivacaine
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthesia, Spinal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ultrasound-assisted

Landmark-guided

Arm Description

Preprocedural ultrasound-assisted paramedian spinal anesthesia will be performed. 0.5% heavy bupivacaine will be injected to intrathecal space for spinal anesthesia.

Landmark-guided spinal anesthesia will be performed, via either midline or paramedian approach. 0.5% heavy bupivacaine will be injected to intrathecal space for spinal anesthesia.

Outcomes

Primary Outcome Measures

the number of needle passes
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 Outcome Measures

Number of spinal needle insertion attempts
the number of times the spinal needle was withdrawn from the skin and reinserted
Time for identifying landmarks
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
time from needle insertion to the completion of injection
dermatome level of sensory block
thoracic dermatome level of sensory block assessed by loss of cold sensation tested with 2% chlorhexidine swab
Incidence of radicular pain, paraesthesia, and blood tapping in the spinal needle
Incidence of radicular pain, paraesthesia, and blood tapping in the spinal needle during the spinal anesthesia procedure
Periprocedural pain
11-point verbal rating scale (0=no pain, 10=most pain imaginable)
Periprocedural discomfort score
11-point verbal rating scale (0=no discomfort, 10=most discomfort imaginable)

Full Information

First Posted
February 27, 2018
Last Updated
January 2, 2019
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03459105
Brief Title
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

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
March 13, 2018 (Actual)
Primary Completion Date
July 4, 2018 (Actual)
Study Completion Date
July 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Spinal, Ultrasonography, Scoliosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound-assisted
Arm Type
Experimental
Arm Description
Preprocedural ultrasound-assisted paramedian spinal anesthesia will be performed. 0.5% heavy bupivacaine will be injected to intrathecal space for spinal anesthesia.
Arm Title
Landmark-guided
Arm Type
Active Comparator
Arm Description
Landmark-guided spinal anesthesia will be performed, via either midline or paramedian approach. 0.5% heavy bupivacaine will be injected to intrathecal space for spinal anesthesia.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-assisted paramedian spinal anesthesia
Other Intervention Name(s)
sono-assisted
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Landmark-guided spinal anesthesia
Other Intervention Name(s)
conventional
Intervention Description
Spinal anesthesia will be done using conventional landmark-guided technique.
Intervention Type
Drug
Intervention Name(s)
0.5% heavy bupivacaine
Other Intervention Name(s)
bupivacaine
Intervention Description
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.
Primary Outcome Measure Information:
Title
the number of needle passes
Description
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
Time Frame
Intraoperative (from the first insertion of needle to patient's skin, until the completion of spinal anesthetic injection)
Secondary Outcome Measure Information:
Title
Number of spinal needle insertion attempts
Description
the number of times the spinal needle was withdrawn from the skin and reinserted
Time Frame
Intraoperative (from the first insertion of needle to patient's skin, until the completion of spinal anesthetic injection)
Title
Time for identifying landmarks
Description
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 Frame
1 day (time taken for establish the landmark, from start of palpation/US scanning to completion of palpation/scanning)
Title
Time taken for performing spinal anesthetic
Description
time from needle insertion to the completion of injection
Time Frame
Intraoperative (from insertion of the needle to the completion of injection)
Title
dermatome level of sensory block
Description
thoracic dermatome level of sensory block assessed by loss of cold sensation tested with 2% chlorhexidine swab
Time Frame
5, 10, 15 minutes after the completion of spinal anesthetic injection
Title
Incidence of radicular pain, paraesthesia, and blood tapping in the spinal needle
Description
Incidence of radicular pain, paraesthesia, and blood tapping in the spinal needle during the spinal anesthesia procedure
Time Frame
Intraoperative (from the first insertion of needle, until the completion of spinal anesthetic injection)
Title
Periprocedural pain
Description
11-point verbal rating scale (0=no pain, 10=most pain imaginable)
Time Frame
Patients will be asked immediately after the completion of spinal anesthesia
Title
Periprocedural discomfort score
Description
11-point verbal rating scale (0=no discomfort, 10=most discomfort imaginable)
Time Frame
Patients will be asked immediately after the completion of spinal anesthesia

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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) documented scoliosis in preoperative L-S-Spine X-ray (Cobb abgle > 10 degree) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Tae Kim, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21572316
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.
Results Reference
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Ultrasound-assisted Versus Conventional Landmark-guided Spinal Anesthesia in Patients With Abnormal Spinal Anatomy

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