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

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.

Study Overview

• Status: Recruiting
• Conditions: Realtime Ultrasound
• Intervention / Treatment: Device: Parasagittal oblique technique (Ultrasound); Device: Paramedian tranverse technique (Ultrasound)

• Study Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marwan Rizk, MD; Phone Number: 6380 +961 01 350 000; Email: mr04@aub.edu.lb

Study Locations

• Lebanon
  • Beirut, Lebanon
    • Recruiting
    • American University of Beirut Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of successful Dural puncture on the first needle insertion attempt	Successful needle insertion on the first attempt	At the begining of the procedure (during the needle insertion)

Collaborators and Investigators

• Sponsor: American University of Beirut Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 15, 2020
• Primary Completion (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: December 28, 2019
• First Submitted That Met QC Criteria: December 28, 2019
• First Posted (ACTUAL): January 2, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 1, 2023
• Last Update Submitted That Met QC Criteria: January 31, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: BIO-2018-0589

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No