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

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

Study Overview

• Status: Completed
• Conditions: Obesity; Ultrasonography; Anesthesia, Spinal; Body Mass Index
• Intervention / Treatment: Procedure: cutaneous landmarks; Device: Accuro

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.

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40136
    • Istituto Ortopedico Rizzoli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Conventional landmark-guided technique; In this arm spinal anesthesia will be performed by using conventional cutaneous landmarks	Procedure: cutaneous landmarks; spinal anesthesia injection based on identification of entry site with palpation of cutaneous landmarks
EXPERIMENTAL: Accuro device guided technique; 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; spinal anesthesia injection based on identification of entry site with pre-procedural ultrasound scan with Accuro device

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 31, 2017
• Primary Completion (ACTUAL): April 3, 2018
• Study Completion (ACTUAL): April 3, 2018

Study Registration Dates

• First Submitted: March 6, 2017
• First Submitted That Met QC Criteria: March 8, 2017
• First Posted (ACTUAL): March 9, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 1, 2019
• Last Update Submitted That Met QC Criteria: January 30, 2019
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: IOR-ACCURO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes