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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03075488
Other study ID # IOR-ACCURO
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 31, 2017
Est. completion date April 3, 2018

Study information

Verified date July 2018
Source Istituto Ortopedico Rizzoli
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 130
Est. completion date April 3, 2018
Est. primary completion date April 3, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Accuro
spinal anesthesia injection based on identification of entry site with pre-procedural ultrasound scan with Accuro device
Procedure:
cutaneous landmarks
spinal anesthesia injection based on identification of entry site with palpation of cutaneous landmarks

Locations

Country Name City State
Italy Istituto Ortopedico Rizzoli Bologna

Sponsors (1)

Lead Sponsor Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

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