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

NCT03459105 | Completed

• 1 other identifier: 1801-107-917
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia, Spinal; Ultrasonography; Scoliosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Number of spinal needle insertion attempts

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

• Time for identifying landmarks

  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

  Intraoperative (from insertion of the needle to the completion of injection)

• dermatome level of sensory block

  5, 10, 15 minutes after the completion of spinal anesthetic injection

• Incidence of radicular pain, paraesthesia, and blood tapping in the spinal needle

  Intraoperative (from the first insertion of needle, until the completion of spinal anesthetic injection)

Study Arms (2)

Ultrasound-assisted

EXPERIMENTAL

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; Drug: 0.5% heavy bupivacaine

Landmark-guided

ACTIVE COMPARATOR

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.

Procedure: Landmark-guided spinal anesthesia; Drug: 0.5% heavy bupivacaine

Interventions

Ultrasound-assisted paramedian spinal anesthesia PROCEDURE

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.

Also known as: sono-assisted

Ultrasound-assisted

Landmark-guided spinal anesthesia PROCEDURE

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

Also known as: conventional

Landmark-guided

0.5% heavy bupivacaine DRUG

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.

Also known as: bupivacaine

Landmark-guided; Ultrasound-assisted

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (1)

• 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.

  PMID: 21572316 BACKGROUND

MeSH Terms

Conditions

Scoliosis

Interventions

Congresses as Topic; Bupivacaine

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Jin-Tae Kim, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 8, 2018
• Study Start: March 13, 2018
• Primary Completion: July 4, 2018
• Study Completion: July 5, 2018
• Last Updated: January 3, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)