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

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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

Tracking Information
First Submitted Date  ICMJE March 6, 2017
First Posted Date  ICMJE March 9, 2017
Last Update Posted Date February 1, 2019
Actual Study Start Date  ICMJE March 31, 2017
Actual Primary Completion Date April 3, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2017)
  • Number of needle insertions [ Time Frame: duration of spinal injection procedure ]
    Number of needle insertions through the skin
  • Procedure duration [ Time Frame: duration of spinal injection procedure ]
    Procedure duration from steril gloves wearing to the end of the spinal anesthetic injection
  • Side effects and complications [ Time Frame: 36 months ]
    To check if present side effects and complications during the procedure
  • Procedure failure [ Time Frame: duration of surgical procedure ]
    To check eventually procedure failure and the need of using alternative anesthesia technique
  • Patient satisfaction [ Time Frame: 24 hours ]
    Evaluation of patient satisfaction and procedure-related pain 24 hours after spinal injection
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ultrasound Prescan vs Conventional Landmark-guided Technique in Spinal Anesthesia in Orthopedic Obese Patients
Official Title  ICMJE Ultrasound Pre-procedural Scan vs Conventional Landmark-guided Technique in Spinal Anesthesia in Orthopedic Obese Patients
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
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Ultrasonography
  • Anesthesia, Spinal
  • Body Mass Index
  • Obesity
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Conventional landmark-guided technique
    In this arm spinal anesthesia will be performed by using conventional cutaneous landmarks
    Intervention: Procedure: 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
    Intervention: Device: Accuro
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. pii: rapm-2019-100538. doi: 10.1136/rapm-2019-100538. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 10, 2018)
130
Original Estimated Enrollment  ICMJE
 (submitted: March 8, 2017)
90
Actual Study Completion Date  ICMJE April 3, 2018
Actual Primary Completion Date April 3, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03075488
Other Study ID Numbers  ICMJE IOR-ACCURO
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Daniela Ghisi, Istituto Ortopedico Rizzoli
Study Sponsor  ICMJE Istituto Ortopedico Rizzoli
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Istituto Ortopedico Rizzoli
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP