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

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.

Study Overview

• Status: Completed
• Conditions: Scoliosis; Ultrasonography; Anesthesia, Spinal
• Intervention / Treatment: Procedure: Ultrasound-assisted paramedian spinal anesthesia; Drug: 0.5% heavy bupivacaine; Procedure: Landmark-guided spinal anesthesia

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultrasound-assisted; Preprocedural ultrasound-assisted paramedian spinal anesthesia will be performed. 0.5% heavy bupivacaine will be injected to intrathecal space for spinal anesthesia.	Procedure: Ultrasound-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.; Other Names: sono-assisted; Drug: 0.5% heavy bupivacaine; 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.; Other Names: bupivacaine
Active Comparator: Landmark-guided; 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.	Drug: 0.5% heavy bupivacaine; 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.; Other Names: bupivacaine; Procedure: Landmark-guided spinal anesthesia; Spinal anesthesia will be done using conventional landmark-guided technique.; Other Names: conventional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Intraoperative (from the first insertion of needle to patient's skin, until the completion of spinal anesthetic injection)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of spinal needle insertion attempts	the number of times the spinal needle was withdrawn from the skin and reinserted	Intraoperative (from the first insertion of needle to patient's skin, until the completion of spinal anesthetic injection)
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.	1 day (time taken for establish the landmark, from start of palpation/US scanning to completion of palpation/scanning)
Time taken for performing spinal anesthetic	time from needle insertion to the completion of injection	Intraoperative (from insertion of the needle 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	5, 10, 15 minutes after the completion of spinal anesthetic injection
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	Intraoperative (from the first insertion of needle, until the completion of spinal anesthetic injection)
Periprocedural pain	11-point verbal rating scale (0=no pain, 10=most pain imaginable)	Patients will be asked immediately after the completion of spinal anesthesia
Periprocedural discomfort score	11-point verbal rating scale (0=no discomfort, 10=most discomfort imaginable)	Patients will be asked immediately after the completion of spinal anesthesia

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2018
• Primary Completion (Actual): July 4, 2018
• Study Completion (Actual): July 5, 2018

Study Registration Dates

• First Submitted: February 27, 2018
• First Submitted That Met QC Criteria: March 7, 2018
• First Posted (Actual): March 8, 2018

Study Record Updates

• Last Update Posted (Actual): January 3, 2019
• Last Update Submitted That Met QC Criteria: January 2, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics, Local; Anesthetics; Bupivacaine
• Other Study ID Numbers: 1801-107-917

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No