An interventional study of Accuro and cutaneous landmarks in Ultrasonography, Anesthesia, Spinal and Body Mass Index, sponsored by Istituto Ortopedico Rizzoli. Completed at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-02-01.
Sponsored by Istituto Ortopedico Rizzoli · Not applicable, Interventional, and Other
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
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:
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.
Istituto Ortopedico Rizzoli is the lead sponsor of 298 studies on the registry; 102 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
In this arm spinal anesthesia will be performed by using conventional cutaneous landmarks
Procedure: cutaneous landmarks
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
spinal anesthesia injection based on identification of entry site with palpation of cutaneous landmarks
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
Time frame: duration of spinal injection procedure
Number of needle insertions
Number of needle insertions through the skin
Time frame: duration of spinal injection procedure
Procedure duration
Procedure duration from steril gloves wearing to the end of the spinal anesthetic injection
Time frame: duration of spinal injection procedure
Side effects and complications
To check if present side effects and complications during the procedure
Time frame: 36 months
Procedure failure
To check eventually procedure failure and the need of using alternative anesthesia technique
Time frame: duration of surgical procedure
Patient satisfaction
Evaluation of patient satisfaction and procedure-related pain 24 hours after spinal injection
Time frame: 24 hours
Plan to share: No
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Istituto Ortopedico Rizzoli