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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03075488
Enrollment
130
Registered
2017-03-09
Start date
2017-03-31
Completion date
2018-04-03
Last updated
2019-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Spinal, Body Mass Index, Obesity, Ultrasonography

Brief summary

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

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.

Interventions

DEVICEAccuro

spinal anesthesia injection based on identification of entry site with pre-procedural ultrasound scan with Accuro device

PROCEDUREcutaneous landmarks

spinal anesthesia injection based on identification of entry site with palpation of cutaneous landmarks

Sponsors

Istituto Ortopedico Rizzoli
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Needle redirectionsduration of spinal injection procedureTo evaluate if there is a significant difference about numbers of needle redirections between conventional landmark guided technique and Accuro device guided technique

Secondary

MeasureTime frameDescription
Number of needle insertionsduration of spinal injection procedureNumber of needle insertions through the skin
Procedure durationduration of spinal injection procedureProcedure duration from steril gloves wearing to the end of the spinal anesthetic injection
Side effects and complications36 monthsTo check if present side effects and complications during the procedure
Procedure failureduration of surgical procedureTo check eventually procedure failure and the need of using alternative anesthesia technique
Patient satisfaction24 hoursEvaluation of patient satisfaction and procedure-related pain 24 hours after spinal injection

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026