A Trial on Ultrasound-assisted Spinal Anaesthesia

February 27, 2013 updated by: Changi General Hospital

A Randomised Controlled Trial on Ultrasound-assisted Spinal Anaesthesia

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 529889
        • Changi General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrasound-assisted
Pre-procedural ultrasound scan performed
Procedure: Ultrasound scan
Pre-procedural ultrasound scan was performed
No Intervention: Manual Palpation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Success Rate of First-attempt of Spinal Anaesthesia
Time Frame: During procedure
During procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
Time Taken to Perform Spinal Anaesthesia
Time Frame: During procedure
During procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changi General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

September 30, 2012

First Submitted That Met QC Criteria

October 2, 2012

First Posted (Estimate)

October 3, 2012

Study Record Updates

Last Update Posted (Estimate)

April 9, 2013

Last Update Submitted That Met QC Criteria

February 27, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • UGSA/2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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