Real Time Ultrasound Guided Spinal Anesthesia in Elderly Patients: Paramedian Transverse Versus Parasagittal Oblique Approach

Sponsor

American University of Beirut Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04214574

Collaborator

(none)

Enrollment

Arms

34.5

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

In this prospective randomized observational study, we aim to compare real time ultrasound-guided paramedian technique using parasagittal oblique view with real time ultrasound-guided paramedian technique using the paramedian transverse median view. Our aim is to find the most suitable real time ultrasound guided approach with regard to ease of performance defined as success rate at first attempt, number of puncture attempts, spinal procedure time, and patient satisfaction.

Condition or Disease	Intervention/Treatment	Phase
Realtime Ultrasound	Device: Parasagittal oblique technique (Ultrasound) Device: Paramedian tranverse technique (Ultrasound)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

84 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

Due to the nature of the study, blinding of the patients and anesthesiologist is not possible

Primary Purpose:

Treatment

Official Title:

Real Time Ultrasound Guided Spinal Anesthesia in Elderly Patients: Paramedian Transverse Versus Parasagittal Oblique Approach

Anticipated Study Start Date :

Jan 15, 2020

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Real time ultrasound-guided Parasagittal oblique technique	Device: Parasagittal oblique technique (Ultrasound) the probe will be placed in a parasagittal plane to identify the articular processes then the sacrum will be identified. The probe will be moved cephalad in the parasagittal axis until the identification of the target lumbar interspaces L2-L3, L3-L4 or L4-L5. Once the appropriate lumbar interspace is identified, the probe will be tilted 45 degree towards the midline into a parasagittal oblique view. The needle will be inserted in plane from the caudal end of the ultrasound transducer with its tip directed towards the interlaminar space under real-time in-plane US guidance.
Experimental: Real time ultrasound-guided paramedian tranverse technique	Device: Paramedian tranverse technique (Ultrasound) the transducer will be applied in the parasagittal plane, and after identification of the intervertebral level, the probe will be rotated 90 degrees into a transverse orientation and centered on the neuraxial midline in a way to align the beam with the interspinous and interlaminar space and thus to get a paramedian transverse interlaminar view. The needle will be inserted in plane from the lateral end of the ultrasound transducer with its tip directed towards the medial border of the articular process.

Arm

Intervention/Treatment

Experimental: Real time ultrasound-guided Parasagittal oblique technique

Device: Parasagittal oblique technique (Ultrasound)

the probe will be placed in a parasagittal plane to identify the articular processes then the sacrum will be identified. The probe will be moved cephalad in the parasagittal axis until the identification of the target lumbar interspaces L2-L3, L3-L4 or L4-L5. Once the appropriate lumbar interspace is identified, the probe will be tilted 45 degree towards the midline into a parasagittal oblique view. The needle will be inserted in plane from the caudal end of the ultrasound transducer with its tip directed towards the interlaminar space under real-time in-plane US guidance.

Experimental: Real time ultrasound-guided paramedian tranverse technique

Device: Paramedian tranverse technique (Ultrasound)

the transducer will be applied in the parasagittal plane, and after identification of the intervertebral level, the probe will be rotated 90 degrees into a transverse orientation and centered on the neuraxial midline in a way to align the beam with the interspinous and interlaminar space and thus to get a paramedian transverse interlaminar view. The needle will be inserted in plane from the lateral end of the ultrasound transducer with its tip directed towards the medial border of the articular process.

Outcome Measures

Primary Outcome Measures

Rate of successful Dural puncture on the first needle insertion attempt [At the begining of the procedure (during the needle insertion)]
Successful needle insertion on the first attempt

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

patients aged more than 65 years
American Society of Anesthesiologists physical status 1 to 3
Can give informed consent
scheduled for surgery amenable to spinal anesthesia

Exclusion Criteria:

Inability to give consent
Patient refusal
Contraindications to spinal anesthesia including coagulopathy
INR>1.5
Platelet count< 75 × 109/L
Indeterminate neurologic disease
Local infection at the site of injection
Allergy to local anesthetics
Patients with back deformities (scoliosis, kyphosis, and with prior operations in the same area of the surgery)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

American University of Beirut Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Marwan Rizk, Dr., American University of Beirut Medical Center

ClinicalTrials.gov Identifier:

NCT04214574

Other Study ID Numbers:

BIO-2018-0589

First Posted:

Jan 2, 2020

Last Update Posted:

Jan 2, 2020

Last Verified:

Dec 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jan 2, 2020