Ultrasound Prescan vs Conventional Landmark-guided Technique in Spinal Anesthesia in Orthopedic Obese Patients

Study Overview
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Brief Summary
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The study is aimed at evaluating whether ultrasound pre-procedural scan with Accuro may reduce needle redirections when performing spinal injection in patients with BMI = or > 30 in orthopedic surgery

Detailed Description
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This is a open-label randomised controlled study. 90 patients will be recruited and divided into two groups of 45 patients per group. Patient recruitment will be performed by patient visit and checking inclusions and exclusion criteria. After written informed consent, every single patient will be allocated in one of the two groups following a computer generated randomization list. Patients in both groups will undergo: standard monitoring with Non Invasive Blood Pressure (NIBP) cuff, three-lead electrocardiography (ECG) and Pulse-oximetry (SpO2). Peripheral intravenous access Sedation (as prescribed by the OR anesthesiologist) Spinal anesthesia performed by anesthesiologists skilled in both techniques (conventional landmark technique or Accuro guided) at the L3-L4, L4-L5 or L5-S1 level, with a 25 or 27 Gauge needle, with the surgical side declive or proclive according to the baricity of the local anesthetic used (sitting position, when needed, will be reported in the CRF) In both groups an observer will monitor and register spinal procedure duration (starting point: anesthesiologist wearing sterile gloves, ending point: end of local anesthetic injection). Control group (landmark technique): The anesthesiologist will identify lumbar spinous processes with traditional landmark palpation. Once the correct interspinous level and the mid-line will be identified, the anesthesiologist will proceed with needle insertion and spinal injection. Treatment group (ultrasound pre-procedural scan with Accuro): By using Accuro US probe the anesthesiologist will perform a pre-procedural lumbar spine scan to detect the needle entry site. After image optimization, the Accuro probe will be aligned with the spine mid-line, as indicated by a dashed red-line on the screen. After that the interlaminar space at the desired intervertebral level will be detected, as indicated by orange overlay in the screen. The depth and the device angle used to detect the interlaminar space will be annotated. The anesthesiologist will then disengage the Accuro Locator needle guide and press gently against the skin. Then the probe will be removed and the spinal injection will be performed.

Official Title
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Ultrasound Pre-procedural Scan vs Conventional Landmark-guided Technique in Spinal Anesthesia in Orthopedic Obese Patients

Conditions
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Ultrasonography, Anesthesia, Spinal, Body Mass Index, Obesity

Intervention / Treatment
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* Device: Accuro
* Procedure: cutaneous landmarks


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 75 years BMI ≥ 30 kg/m2 American Society of Anesthesiologists' (ASA) classification I-III Orthopedic surgery to be performed under spinal anesthesia Able to understand and to sign informed consent Exclusion Criteria: Local anaesthetic allergy Serious spine deformities Previous spine surgery Inability to express informed consent Contraindications to spinal anaesthesia Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional landmark-guided technique<br>In this arm spinal anesthesia will be performed by using conventional cutaneous landmarks | Procedure: cutaneous landmarks<br>* spinal anesthesia injection based on identification of entry site with palpation of cutaneous landmarks<br>|
| Experimental: Accuro device guided technique<br>In this arm spinal anesthesia will be performed only after having detected the intralaminar space, the mid-line, the depth and the orientation for spinal needle insertion with pre-procedural scan performed with Accuro device | Device: Accuro<br>* spinal anesthesia injection based on identification of entry site with pre-procedural ultrasound scan with Accuro device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Needle redirections | To evaluate if there is a significant difference about numbers of needle redirections between conventional landmark guided technique and Accuro device guided technique | duration of spinal injection procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of needle insertions | Number of needle insertions through the skin | duration of spinal injection procedure | 
| Procedure duration | Procedure duration from steril gloves wearing to the end of the spinal anesthetic injection | duration of spinal injection procedure | 
| Side effects and complications | To check if present side effects and complications during the procedure | 36 months | 
| Procedure failure | To check eventually procedure failure and the need of using alternative anesthesia technique | duration of surgical procedure | 
| Patient satisfaction | Evaluation of patient satisfaction and procedure-related pain 24 hours after spinal injection | 24 hours |