NCT01699373

Brief Summary

A randomised controlled trial comparing the use of pre-procedural ultrasound scanning with manual palpation to identify landmarks for performance of spinal anaesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2011

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

Study Start

First participant enrolled

April 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 3, 2012

Completed
6 months until next milestone

Results Posted

Study results publicly available

April 9, 2013

Completed
Last Updated

April 9, 2013

Status Verified

February 1, 2013

Enrollment Period

1 year

First QC Date

September 30, 2012

Results QC Date

February 27, 2013

Last Update Submit

February 27, 2013

Conditions

Spinal AnaesthesiaUltrasound

Outcome Measures

Primary Outcomes (1)

  • Success Rate of First-attempt of Spinal Anaesthesia

    During procedure

Secondary Outcomes (1)

  • Time Taken to Perform Spinal Anaesthesia

    During procedure

Study Arms (2)

Ultrasound-assisted

EXPERIMENTAL

Pre-procedural ultrasound scan performed

Procedure: Ultrasound scan

Manual Palpation

NO INTERVENTION

Interventions

Ultrasound scanPROCEDURE

Pre-procedural ultrasound scan was performed

Ultrasound-assisted

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I to III
  • undergoing surgery amenable to spinal anaesthesia

You may not qualify if:

  • Patient refusal
  • contraindications to regional anaesthesia
  • known allergy to local anaesthetics
  • bleeding diathesis
  • inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changi General Hospital

Singapore, Singapore, 529889, Singapore

Location

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Limitations and Caveats

Baseline characteristics not equal

Results Point of Contact

Title
Dr Lim Yean Chin
Organization
Changi General Hospital
yean_chin_lim@cgh.com.sg
+65 68503831

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2012

First Posted

October 3, 2012

Study Start

April 1, 2011

Primary Completion

April 1, 2012

Study Completion

May 1, 2012

Last Updated

April 9, 2013

Results First Posted

April 9, 2013

Record last verified: 2013-02

Locations

SG(1)