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OpenTrials
Completed

NCT Number: NCT01570491

A Real-Time Ultrasound Guided Approach For Spinal Anesthesia

Our goal was to compare the number of attempts to perform spinal anesthesia using real-time ultrasound guidance versus landmark technique in patients meeting predefined criteria for difficult spinal anesthesia.

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Key information

Conditions

Patients Aged 55 or Older BMI More Than 40 kg/m2 Bone Diseases Musculoskeletal Diseases Scoliosis Spinal Curvatures Spinal Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

About this study

Patients who consent to receive spinal anesthesia (as opposed to some other anesthetic technique) and who meet the inclusion/exclusion criteria for the study (given below) will be randomized on day of surgery after obtaining informed consent to either ultrasound-guided or standard spinal anesthesia technique.

A block randomization scheme with random block sizes ranging from 2-8 patients will be used. The outcomes will be recorded by a third party observer in the block room/operating room who might be a nurse or resident or clinical research fellow not directly involved with performing the block. The post procedure outcomes will also be recorded by a clinical research fellow or resident who was not directly involved with performing the block.

No sample size estimation methodology currently exists for the right-censored count data models. We expect less number of attempts in the ultrasound group a 20 % difference between the two groups which we feel is a minimum of a clinically-relevant effect. At the 0.05 level of significance with a power of 0.8, we will require a minimum of 20 patients per group,therefore we plan to recruit 40 patients in total.

The analysis will be conducted by a statistician who will be blinded.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 55 or older
  • BMI more than 40
  • Scoliosis

Exclusion criterion:

1 Patients who have undergone previous Spine Surgery

Treatment and study plan

ultrasound-guided spinal anesthesia

Other

ultrasound-guided technique for block placement

standard spinal anesthesia

Other

Anesthesiologist will use standard technique for placement of spinal block.

Primary outcomes

  1. Number of Attempts

    Time frame: 10-15 minutes before the surgery

    Number of attempts (defined as number of needle reinsertions form the skin and NOT number of redirection of the needle) at the beginning of surgery

Secondary outcomes

  1. Difficulty of Block Insertion

    Time frame: 10-15 minutes before the surgery

    Difficulty of insertion, was rated by the performing anesthesiologist on a 10-point Likert scale from one (easy) to ten (extremely difficult)

  2. Patient Satisfaction

    Time frame: after insert the block but before the surgery

    Record patient satisfaction on a five-point Likert scale, where a value of 1 indicates extremely unsatisfied and a value of 5 indicates extremely satisfied.

  3. Time to Perform Block (Second)

    Time frame: as measured in seconds after needle insertion, surgical date

    Time to perform block (from first needle insertion to injection of medication)

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

Cardiothoracic Anesthesia and Critical Care Patient Registry

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Apr 4, 2012
Registry last updated
Jul 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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