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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional landmark-guided technique | Active Comparator | In this arm spinal anesthesia will be performed by using conventional 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accuro | Device | spinal anesthesia injection based on identification of entry site with pre-procedural ultrasound scan with Accuro device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of needle insertions | Number of needle insertions through the skin | duration of spinal injection procedure |
| Procedure duration | Procedure duration from steril gloves wearing to the end of the spinal anesthetic injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Ortopedico Rizzoli | Bologna | 40136 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31653795 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 31, 2021 | |
| Reset | Aug 25, 2021 | |
| Release | May 30, 2023 | |
| Reset | Jun 21, 2023 | |
| Release | Jun 22, 2023 | |
| Reset | Jul 12, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 31, 2021 | Aug 25, 2021 | |||
| May 30, 2023 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| cutaneous landmarks | Procedure | spinal anesthesia injection based on identification of entry site with palpation of cutaneous landmarks |
|
| duration of spinal injection procedure |
| Side effects and complications | To check if present side effects and complications during the procedure | 36 months |
| Procedure failure | To check eventually procedure failure and the need of using alternative anesthesia technique | duration of surgical procedure |
| Patient satisfaction | Evaluation of patient satisfaction and procedure-related pain 24 hours after spinal injection | 24 hours |
| Jun 21, 2023 |
| Jun 22, 2023 | Jul 12, 2023 |
| Sep 22, 2023 | Oct 16, 2023 | 6 |
| Oct 17, 2023 | Nov 7, 2023 | 7 |
| Mar 20, 2024 | Apr 16, 2024 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |