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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03075488
Recruitment Status : Completed
First Posted : March 9, 2017
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
Daniela Ghisi, Istituto Ortopedico Rizzoli

Study Description
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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

Condition or disease Intervention/treatment Phase
Ultrasonography Anesthesia, Spinal Body Mass Index Obesity Device: Accuro Procedure: cutaneous landmarks Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Ultrasound Pre-procedural Scan vs Conventional Landmark-guided Technique in Spinal Anesthesia in Orthopedic Obese Patients
Actual Study Start Date : March 31, 2017
Actual Primary Completion Date : April 3, 2018
Actual Study Completion Date : April 3, 2018
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Needle redirections [ Time Frame: duration of spinal injection procedure ]
    To evaluate if there is a significant difference about numbers of needle redirections between conventional landmark guided technique and Accuro device guided technique


Secondary Outcome Measures :
  1. Number of needle insertions [ Time Frame: duration of spinal injection procedure ]
    Number of needle insertions through the skin

  2. Procedure duration [ Time Frame: duration of spinal injection procedure ]
    Procedure duration from steril gloves wearing to the end of the spinal anesthetic injection

  3. Side effects and complications [ Time Frame: 36 months ]
    To check if present side effects and complications during the procedure

  4. Procedure failure [ Time Frame: duration of surgical procedure ]
    To check eventually procedure failure and the need of using alternative anesthesia technique

  5. Patient satisfaction [ Time Frame: 24 hours ]
    Evaluation of patient satisfaction and procedure-related pain 24 hours after spinal injection


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03075488


Locations
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Italy
Istituto Ortopedico Rizzoli
Bologna, Italy, 40136
Sponsors and Collaborators
Istituto Ortopedico Rizzoli
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Daniela Ghisi, principal investigator, Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier: NCT03075488    
Other Study ID Numbers: IOR-ACCURO
First Posted: March 9, 2017    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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