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

NCT ID: NCT03459105

Last Updated: 2019-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-13

Study Completion Date

2018-07-05

Brief Summary

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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.

Detailed Description

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Conditions

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Anesthesia, Spinal Ultrasonography Scoliosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Ultrasound-assisted

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

Group Type EXPERIMENTAL

Ultrasound-assisted paramedian spinal anesthesia

Intervention Type 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.

0.5% heavy bupivacaine

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Landmark-guided spinal anesthesia

Intervention Type PROCEDURE

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

0.5% heavy bupivacaine

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Landmark-guided spinal anesthesia

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

Intervention Type PROCEDURE

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.

Intervention Type DRUG

Other Intervention Names

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sono-assisted conventional bupivacaine

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jin-Tae Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jin-Tae Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 21572316 (View on PubMed)

Other Identifiers

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1801-107-917

Identifier Type: -

Identifier Source: org_study_id

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