UltrasonographyNCT03075488
Ultrasound Prescan vs Conventional Landmark-guided Technique in Spinal Anesthesia in Orthopedic Obese Patients
A study testing Accuro and cutaneous landmarks in people with Ultrasonography and Anesthesia, Spinal, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ultrasonography, Anesthesia, Spinal, Body Mass Index
- What is being tested?
- Accuro and cutaneous landmarks
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteItaly
- Study dates
- 31 Mar 2017to 3 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Local anaesthetic allergy
- Serious spine deformities
- Previous spine surgery
- Inability to express informed consent
- Contraindications to spinal anaesthesia
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Pre-procedural Scan vs Conventional Landmark-guided Technique in Spinal Anesthesia in Orthopedic Obese Patients
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
Read the 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.
- Conditions
- Ultrasonography, Anesthesia, Spinal, Body Mass Index, Obesity
- Being tested
- Accuro, cutaneous landmarks
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AccuroDevice
spinal anesthesia injection based on identification of entry site with pre-procedural ultrasound scan with Accuro device
cutaneous landmarksProcedure or surgery
spinal anesthesia injection based on identification of entry site with palpation of cutaneous landmarks
| Study group | Role | What they receive |
|---|---|---|
| Conventional landmark-guided technique | Active comparator | In this arm spinal anesthesia will be performed by using conventional cutaneous landmarks Receives: Procedure: 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 Receives: Device: Accuro |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: duration of spinal injection procedure
Secondary outcomes (5)
Number of needle insertions
Number of needle insertions through the skin
Measured: duration of spinal injection procedure
Procedure duration
Procedure duration from steril gloves wearing to the end of the spinal anesthetic injection
Measured: duration of spinal injection procedure
Side effects and complications
To check if present side effects and complications during the procedure
Measured: 36 months
Procedure failure
To check eventually procedure failure and the need of using alternative anesthesia technique
Measured: duration of surgical procedure
Patient satisfaction
Evaluation of patient satisfaction and procedure-related pain 24 hours after spinal injection
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start31 Mar 2017
- Primary completion3 Apr 2018
- Study completion3 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UltrasonographyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniela Ghisi, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03075488
- Sponsor's protocol ID
- IOR-ACCURO
- Status last verified
- Jul 2018
- First submitted
- 6 Mar 2017
- Last updated
- 1 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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:rapm-2019-100538. doi: 10.1136/rapm-2019-100538. Online ahead of print.
PubMed 31653795
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Pre-procedural Scan vs Conventional Landmark-guided Technique in Spinal Anesthesia in Orthopedic Obese Patients
- ClinicalTrials.gov ID
- NCT03075488
- Acronym / sponsor ID
- IOR-ACCURO
- Conditions
- Ultrasonography, Anesthesia, Spinal, Body Mass Index, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 31 Mar 2017 (actual)
- Primary completion
- 3 Apr 2018 (actual)
- Study completion
- 3 Apr 2018 (actual)
- First posted
- 9 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional landmark-guided technique | Active comparator | Procedure: cutaneous landmarksIn this arm spinal anesthesia will be performed by using conventional cutaneous landmarks |
| Accuro device guided technique | Experimental | Device: AccuroIn 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Local anaesthetic allergy
- Serious spine deformities
- Previous spine surgery
- Inability to express informed consent
- Contraindications to spinal anaesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accurospinal anesthesia injection based on identification of entry site with pre-procedural ultrasound scan with Accuro device | Device | Accuro device guided technique |
| cutaneous landmarksspinal anesthesia injection based on identification of entry site with palpation of cutaneous landmarks | Procedure or surgery | Conventional landmark-guided technique |
Primary outcome
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
5 secondary outcomes
Number of needle insertions
Time frame: duration of spinal injection procedure
Procedure duration
Time frame: duration of spinal injection procedure
Side effects and complications
Time frame: 36 months
Procedure failure
Time frame: duration of surgical procedure
Patient satisfaction
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
- Derived from this study: PubMed 31653795Ghisi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accuro and cutaneous landmarks in people with Ultrasonography and Anesthesia, Spinal, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Needle redirections (time frame: duration of spinal injection procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03075488, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2019.