A Real-Time Ultrasound Guided Approach For Spinal Anesthesia

Scoliosis Clinical Trial

Official title:

Cardiothoracic Anesthesia and Critical Care Patient Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01570491
• Other study ID #: 11-1171
• Status: Completed
• Phase: N/A
• Start date: March 2012
• Est. completion date: December 2016

Study information

• Verified date: July 2019
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

1. Patients aged 55 or older

2. BMI more than 40

3. Scoliosis

Exclusion criterion:

1 Patients who have undergone previous Spine Surgery

Related Conditions & MeSH terms

• BMI More Than 40 kg/m2
• Patients Aged 55 or Older
• Scoliosis

Intervention

Other:
• ultrasound-guided spinal anesthesia
ultrasound-guided technique for block placement
• standard spinal anesthesia
Anesthesiologist will use standard technique for placement of spinal block.

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Attempts	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	10-15 minutes before the surgery
Secondary	Difficulty of Block Insertion	Difficulty of insertion, was rated by the performing anesthesiologist on a 10-point Likert scale from one (easy) to ten (extremely difficult)	10-15 minutes before the surgery
Secondary	Patient Satisfaction	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.	after insert the block but before the surgery
Secondary	Time to Perform Block (Second)	Time to perform block (from first needle insertion to injection of medication)	as measured in seconds after needle insertion, surgical date