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

NCT03075488 | Completed FDA Device

• 1 other identifier: IOR-ACCURO
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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

Conditions

Ultrasonography; Anesthesia, Spinal; Body Mass Index; Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Number of needle insertions

  duration of spinal injection procedure

• Procedure duration

  duration of spinal injection procedure

• Side effects and complications

  36 months

• Procedure failure

  duration of surgical procedure

• Patient satisfaction

  24 hours

Study Arms (2)

Conventional landmark-guided technique

ACTIVE COMPARATOR

In this arm spinal anesthesia will be performed by using conventional cutaneous landmarks

Procedure: cutaneous landmarks

Accuro device guided technique

EXPERIMENTAL

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

Interventions

Accuro DEVICE

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

Accuro device guided technique

cutaneous landmarks PROCEDURE

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

Conventional landmark-guided technique

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Local anaesthetic allergy
• Serious spine deformities
• Previous spine surgery
• Inability to express informed consent
• Contraindications to spinal anaesthesia
• Pregnancy

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Related Publications (1)

• 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.

  PMID: 31653795 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: March 9, 2017
• Study Start: March 31, 2017
• Primary Completion: April 3, 2018
• Study Completion: April 3, 2018
• Last Updated: February 1, 2019

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)