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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01570491
Other study ID # 11-1171
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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