NCT03679663

Brief Summary

Aim is to investigate the difference in number of attempts to place neuraxial block comparing handheld ultrasound versus use of palpation alone for women with impalpable bony landmarks undergoing spinal anesthesia for elective cesarean delivery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 20, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

December 20, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 4, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2020

Completed
Last Updated

October 5, 2020

Status Verified

January 1, 2020

Enrollment Period

1.6 years

First QC Date

September 17, 2018

Last Update Submit

October 2, 2020

Conditions

Ultrasound

Keywords

ultrasound

Outcome Measures

Primary Outcomes (1)

  • Needle movement

    number of needle redirections, defined as any ventral advancement of the needle and/or introducer, as well as any new intervertebral space attempted.

    10 mins

Secondary Outcomes (3)

  • The insertion site identification time,

    10 mins

  • Patient verbal numerical pain score (0-10) after skin incision.

    10 mins

  • Patient verbal numerical pain score (0-10) after spinal performance. Patient verbal numerical pain score (0-10). Scale is Verbal numerical rating scale, where zero = no pain at all and 10 = maximum possible pain.

    10 mins

Study Arms (2)

Palpation

NO INTERVENTION

Anesthesia performed without ultrasound

Ultrasound

EXPERIMENTAL

Anesthesia performed after ultrasound

Device: Ultrasound

Interventions

UltrasoundDEVICE

Use of ultrasound to identify pre-puncture site

Ultrasound

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Lumbar spinous processes impalpable. Elective caesarean delivery for singleton pregnancies BMI \>30 No contraindications to neuraxial block Signed informed consent Neuraxial Block planned

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcomes will be assessed by an observer who was not in the room when the puncture site was identified and was blinded to the study group. The room set up will be identical with the handheld ultrasound placed visible in all cases, including those randomized to the palpation group.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: RCT
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2018

First Posted

September 20, 2018

Study Start

December 20, 2018

Primary Completion

August 4, 2020

Study Completion

August 4, 2020

Last Updated

October 5, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)