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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03075488
• Other study ID #: IOR-ACCURO
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

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

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