NCT03316352

Brief Summary

Multiple passes and attempts during spinal anesthesia might be associated with a greater incidence of paraesthesia, postdural puncture headache, and spinal hematoma. We hypothesized that the use of a preprocedural ultrasound-assisted paramedian technique for spinal anesthesia in patients with old age would reduce the number of passes required to entry into the subarachnoid space when compared with the landmark-guided paramedian approach. The study participants will be randomized into group L (landmark-guided) and group U (ultrasound-assisted). In group L, spinal anesthesia will be performed via paramedian approach using conventional landmark palpation technique. In group U, a preprocedural ultrasound scan will be used to mark the needle insertion site, and spinal anesthetic will be done via the paramedian approach.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 20, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

October 24, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2018

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

3 months

First QC Date

October 16, 2017

Last Update Submit

August 29, 2018

Conditions

Anesthesia, SpinalUltrasonography

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

    from the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection

Secondary Outcomes (7)

  • Number of spinal needle insertion attempts

    from the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection

  • Time for identifying landmarks

    from the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection

  • Time taken for performing spinal anesthetic

    from the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection

  • Level of block

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

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

    from the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection

  • +2 more secondary outcomes

Study Arms (2)

Ultrasound-assisted

EXPERIMENTAL

Ultrasound-assisted paramedian technique spinal anesthesia will be performed. A Preprocedural ultrasound scan will be performed for skin marking of entry site of spinal needle. Spinal anesthesia will be performed via paramedian approach using the skin marking site as entry point. 0.5% heavy bupivacaine will be administered into intrathecal space.

Procedure: Ultrasound-assisted paramedian technique spinal anesthesiaDevice: UltrasoundDrug: 0.5% heavy bupivacaine

Landmark-guided

ACTIVE COMPARATOR

In these patients, spinal anesthesia will be performed via paramedian approach using conventional landmark palpation technique. Landmark-guided paramedian technique spinal anesthesia will be performed. 0.5% heavy bupivacaine will be administered into intrathecal space.

Procedure: Landmark-guided paramedian technique spinal anesthesiaDrug: 0.5% heavy bupivacaine

Interventions

Ultrasound-assisted paramedian technique spinal anesthesiaPROCEDURE

Ultrasound-assisted paramedian technique will be used. A preprocedural ultrasound scan will be performed, and skin marking for spinal entry site will be done using ultrasound scan. Spinal anesthesia will be done according to skin marking using ultrasound, via paramedian approach.

Also known as: sono-assisted
Ultrasound-assisted
Landmark-guided paramedian technique spinal anesthesiaPROCEDURE

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

Also known as: conventional
Landmark-guided
UltrasoundDEVICE

A preprocedural ultrasound scan will be done using Portable Echocardiography system (Vivid-i, GE healthcare) with 4C-RS convex probe (2.0-5.5 MHz Frequency range).

Also known as: sonography
Ultrasound-assisted
0.5% heavy bupivacaineDRUG

During spinal anesthesia, 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-guidedUltrasound-assisted

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elderly patients (age≥60 years) scheduled to undergoing elective orthopedic surgery under spinal anesthesia
  • Patients with ASA physical status classification I, II, III

You may not qualify if:

  • Patients with contraindication to spinal anesthesia (coagulopathy, local infection, allergy to local anesthetic)
  • Patients with morbid cardiac diseases
  • Pregnancy
  • Patients with previous history of lumbar spine surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (3)

  • Kallidaikurichi Srinivasan K, Iohom G, Loughnane F, Lee PJ. Conventional Landmark-Guided Midline Versus Preprocedure Ultrasound-Guided Paramedian Techniques in Spinal Anesthesia. Anesth Analg. 2015 Oct;121(4):1089-1096. doi: 10.1213/ANE.0000000000000911.

    PMID: 26270115BACKGROUND

  • 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: 21572316BACKGROUND

  • Park SK, Yoo S, Kim WH, Lim YJ, Bahk JH, Kim JT. Ultrasound-assisted vs. landmark-guided paramedian spinal anaesthesia in the elderly: A randomised controlled trial. Eur J Anaesthesiol. 2019 Oct;36(10):763-771. doi: 10.1097/EJA.0000000000001029.

    PMID: 31188153DERIVED

MeSH Terms

Interventions

Congresses as TopicUltrasonographyBupivacaine

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and OrganizationsDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Jin-Tae Kim, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

October 16, 2017

First Posted

October 20, 2017

Study Start

October 24, 2017

Primary Completion

January 11, 2018

Study Completion

January 11, 2018

Last Updated

August 31, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)