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
|Condition or disease||Intervention/treatment||Phase|
|Ultrasonography Anesthesia, Spinal Body Mass Index Obesity||Device: Accuro Procedure: cutaneous landmarks||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
spinal anesthesia injection based on identification of entry site with pre-procedural ultrasound scan with Accuro device
- 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
- 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
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
|Istituto Ortopedico Rizzoli|
|Bologna, Italy, 40136|