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A Trial on Ultrasound-assisted Spinal Anaesthesia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Changi General Hospital
ClinicalTrials.gov Identifier:
NCT01699373
First received: September 30, 2012
Last updated: February 27, 2013
Last verified: February 2013
History of Changes
  Purpose

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


Condition Intervention
Spinal Anaesthesia
Ultrasound
 Procedure: Ultrasound scan

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial on Ultrasound-assisted Spinal Anaesthesia

Resource links provided by NLM:

MedlinePlus related topics: Nuclear Scans
U.S. FDA Resources

Further study details as provided by Changi General Hospital:

Primary Outcome Measures:
  • Success Rate of First-attempt of Spinal Anaesthesia [ Time Frame: During procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time Taken to Perform Spinal Anaesthesia [ Time Frame: During procedure ] [ Designated as safety issue: No ]

Enrollment: 170
Study Start Date: April 2011
Study Completion Date: May 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ultrasound-assisted
Pre-procedural ultrasound scan performed
 Procedure: Ultrasound scan
Pre-procedural ultrasound scan was performed
No Intervention: Manual Palpation

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01699373

Locations
Singapore
Changi General Hospital
Singapore, Singapore, 529889
Sponsors and Collaborators
Changi General Hospital
  More Information

No publications provided

Responsible Party: Changi General Hospital
ClinicalTrials.gov Identifier: NCT01699373     History of Changes
Other Study ID Numbers: UGSA/2010
Study First Received: September 30, 2012
Results First Received: February 27, 2013
Last Updated: February 27, 2013
Health Authority: Singapore: Institutional Review Board

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013