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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014