Clinical trial NCT03075488: Ultrasound Prescan vs Conventional Landmark-guided Technique in Spinal Anesthesia in Orthopedic Obese Patients
Official title: Ultrasound Pre-procedural Scan vs Conventional Landmark-guided Technique in Spinal Anesthesia in Orthopedic Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ultrasonography
Anesthesia, Spinal
Body Mass Index
Obesity
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2017-03-09
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Needle redirections
timeFrame: duration of spinal injection procedure
Secondary outcomes:
measure: Number of needle insertions
timeFrame: duration of spinal injection procedure
measure: Procedure duration
timeFrame: duration of spinal injection procedure
measure: Side effects and complications
timeFrame: 36 months
measure: Procedure failure
timeFrame: duration of surgical procedure
measure: Patient satisfaction
timeFrame: 24 hours
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
References:
citation: Ghisi D, Tomasi M, Giannone S, Luppi A, Aurini L, Toccaceli L, Benazzo A, Bonarelli S. A randomized comparison between Accuro and palpation-guided spinal anesthesia for obese patients undergoing orthopedic surgery. Reg Anesth Pain Med. 2019 Oct 25:rapm-2019-100538. doi: 10.1136/rapm-2019-100538. Online ahead of print.