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Real-Time Ultrasound-guidance Facilitates Paramedian Spinal Anaesthesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02830035
Recruitment Status : Completed
First Posted : July 12, 2016
Last Update Posted : August 8, 2016
Sponsor:
Information provided by (Responsible Party):
Soon Eu Chong, University of Science Malaysia

Brief Summary:
The purpose of this study is to compare the clinical efficacy of real-time ultrasound guidance on spinal anesthesia vs the traditional anatomical landmark technique, by comparing success rate of spinal needle insertion, success rate rate of single needle pass, duration and immediate complications.

Condition or disease Intervention/treatment Phase
Wounds and Injuries Procedure: Real-time Ultrasound-guided Procedure: Anatomical Landmark Technique Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Between Real-Time Ultrasound Guidance vs Anatomical Landmark Technique on the Efficacy of Paramedian Spinal Anaesthesia
Study Start Date : June 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Active Comparator: Anatomical Landmark Technique
Traditional anatomical landmark technique based paramedian spinal anesthesia
Procedure: Anatomical Landmark Technique
Conventional anatomical landmark technique for paramedian spinal anesthesia

Active Comparator: Real-time Ultrasound-guided Technique
Ultrasound-guided paramedian spinal anesthesia Intervention: Ultrasound-guided Technique
Procedure: Real-time Ultrasound-guided
Real-time ultrasound guided paramedian spinal anesthesia




Primary Outcome Measures :
  1. success rate of spinal needle insertion [ Time Frame: during the procedure of spinal anesthesia ]
    The ability of getting a successful spinal anesthesia with a single skin puncture regardless of needle redirection.

  2. success rate of single needle pass [ Time Frame: during the procedure of spinal anesthesia ]
    The ability of getting a successful spinal anesthesia with a single skin puncture and no needle redirection.


Secondary Outcome Measures :
  1. duration of procedure [ Time Frame: during the procedure of spinal anesthesia ]
  2. immediate complication [ Time Frame: immediately after and within 1 week after given spinal anesthesia ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Consented adults aged at least 18 years old.
  • ASA I to III.
  • Presented for lower limb surgery.
  • Fasted for at least 6 hours.

Exclusion Criteria:

  • Patient refusal
  • Contraindication to neuraxial block.
  • Patient on anticoagulant medication, or coagulopathy (INR > 1.5)
  • Patient on double antiplatelet, or thrombocytopenia (platelet < 100)
  • Local infection at site of injection
  • Indeterminate neurological disease
  • Allergy to local anaesthetics
  • Spinal abnormality
  • Pregnancy.
  • Previous surgery to lumbar region.
  • BMI > 30

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02830035


Locations
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Malaysia
Hospital Universiti Sains Malaysia
Kota Bharu, Kelantan, Malaysia, 16150
Sponsors and Collaborators
University of Science Malaysia
Investigators
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Principal Investigator: Soon Eu Chong, MD, MMed University of Science Malaysia
Study Chair: Mohd Nikman Ahmad, MD, MMed University of Science Malaysia

Publications:

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Responsible Party: Soon Eu Chong, Medical Lecturer in Anesthesiology, University of Science Malaysia
ClinicalTrials.gov Identifier: NCT02830035    
Other Study ID Numbers: USM/JEPeM/283.2.(5)
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: August 8, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Soon Eu Chong, University of Science Malaysia:
ultrasound guided
spinal anesthesia
neuraxial block
paramedian
Additional relevant MeSH terms:
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Wounds and Injuries
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs