A Real-Time Ultrasound Guided Approach For Spinal Anesthesia

NCT ID: NCT01570491

Last Updated: 2019-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2016-12-31

Brief 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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

ultrasound-guided spinal anesthesia

participants will randomly assigned to use ultrasound-guided technique for block placement by Anesthesiologist.

Group Type: ACTIVE_COMPARATOR

ultrasound-guided spinal anesthesia

Intervention Type: OTHER

ultrasound-guided technique for block placement

standard spinal anesthesia

randomized participants will be given standard spinal anesthesia insertion technique for block placement by Anesthesiologist

Group Type: PLACEBO_COMPARATOR

standard spinal anesthesia

Intervention Type: OTHER

Anesthesiologist will use standard technique for placement of spinal block.

Interventions

ultrasound-guided spinal anesthesia

ultrasound-guided technique for block placement

Intervention Type: OTHER

standard spinal anesthesia

Anesthesiologist will use standard technique for placement of spinal block.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hesham Elsharkawy, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

11-1171

Identifier Type: -

Identifier Source: org_study_id