UltrasoundAccuroNCT03679663
Ultrasound Versus Palpation for Spinal Anesthesia Success
A study testing Ultrasound in people with Ultrasound, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Aim is to investigate the difference in number of attempts to place neuraxial block comparing handheld ultrasound versus use of palpation alone for women with impalpable bony landmarks undergoing spinal anesthesia for elective cesarean delivery. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Ultrasound
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- 20 Dec 2018to 4 Aug 2020
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Lumbar spinous processes impalpable. Elective caesarean delivery for singleton pregnancies BMI >30 No contraindications to neuraxial block Signed informed consent Neuraxial Block planned
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Controlled Trial to Compare a Handheld Ultrasound Identification of the Neuraxial Block Insertion Site Versus Palpation Only in an Obese Population of Women Undergoing Cesarean Delivery
Aim is to investigate the difference in number of attempts to place neuraxial block comparing handheld ultrasound versus use of palpation alone for women with impalpable bony landmarks undergoing spinal anesthesia for elective cesarean delivery.
Read the detailed description
Patients will be recruited prior to cesarean delivery and their site of lumbar injection will be examined. Women with impalpable bony landmarks will be offered recruitment to the study. Women will be randomly assigned to the standard of care group - palpation attempts only, versus an ultrasound group, where the insertion point will be identified by the handheld ultrasound device
Inclusion criteria:
Lumbar spinous processes impalpable. Elective cesarean delivery for singleton pregnancies BMI >30 No contraindications to neuraxial block Signed informed consent Neuraxial Block planned Exclusion Criteria Refuses informed consent Poor written Hebrew, no spoken English or Hebrew Patients will be randomized into two groups : an ultrasound (US) group and a palpation (PP) group.
The primary outcome of our study is the number of needle redirections, defined as any ventral advancement of the needle and/or introducer, as well as any new intervertebral space attempted.
Secondary outcomes include:
The insertion site identification time, patient verbal numerical pain score (0-10) after skin incision.
- Conditions
- Ultrasound
- Being tested
- Ultrasound
- Keywords
- ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
Use of ultrasound to identify pre-puncture site
| Study group | Role | What they receive |
|---|---|---|
| Palpation | No intervention | Anesthesia performed without ultrasound |
| Ultrasound | Experimental | Anesthesia performed after ultrasound Receives: Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Needle movement
number of needle redirections, defined as any ventral advancement of the needle and/or introducer, as well as any new intervertebral space attempted.
Measured: 10 mins
Secondary outcomes (3)
The insertion site identification time,
time
Measured: 10 mins
Patient verbal numerical pain score (0-10) after skin incision.
Patient verbal numerical pain score (0-10) after skin incision. Scale is Verbal numerical rating scale, where zero = no pain at all and 10 = maximum possible pain.
Measured: 10 mins
Patient verbal numerical pain score (0-10) after spinal performance. Patient verbal numerical pain score (0-10). Scale is Verbal numerical rating scale, where zero = no pain at all and 10 = maximum possible pain.
Patient verbal numerical pain score (0-10) after spinal performance. Patient verbal numerical pain score (0-10) Scale is Verbal numerical rating scale, where zero = no pain at all and 10 = maximum possible pain.
Measured: 10 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2018
- Study start20 Dec 2018
- Primary completion4 Aug 2020
- Study completion4 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UltrasoundStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03679663
- Sponsor's protocol ID
- TASMC-18-CFW-0219-CTIL
- Acronym
- Accuro
- Status last verified
- Jan 2020
- First submitted
- 17 Sep 2018
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Trial to Compare a Handheld Ultrasound Identification of the Neuraxial Block Insertion Site Versus Palpation Only in an Obese Population of Women Undergoing Cesarean Delivery
- ClinicalTrials.gov ID
- NCT03679663
- Acronym / sponsor ID
- Accuro / TASMC-18-CFW-0219-CTIL
- Conditions
- Ultrasound
- Keywords
- ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 4 Aug 2020 (actual)
- Study completion
- 4 Aug 2020 (actual)
- First posted
- 20 Sep 2018 (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.
Aim is to investigate the difference in number of attempts to place neuraxial block comparing handheld ultrasound versus use of palpation alone for women with impalpable bony landmarks undergoing spinal anesthesia for elective cesarean delivery.
Detailed description
Patients will be recruited prior to cesarean delivery and their site of lumbar injection will be examined. Women with impalpable bony landmarks will be offered recruitment to the study. Women will be randomly assigned to the standard of care group - palpation attempts only, versus an ultrasound group, where the insertion point will be identified by the handheld ultrasound device
Inclusion criteria:
Lumbar spinous processes impalpable. Elective cesarean delivery for singleton pregnancies BMI >30 No contraindications to neuraxial block Signed informed consent Neuraxial Block planned Exclusion Criteria Refuses informed consent Poor written Hebrew, no spoken English or Hebrew Patients will be randomized into two groups : an ultrasound (US) group and a palpation (PP) group.
The primary outcome of our study is the number of needle redirections, defined as any ventral advancement of the needle and/or introducer, as well as any new intervertebral space attempted.
Secondary outcomes include:
The insertion site identification time, patient verbal numerical pain score (0-10) after skin incision.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Palpation | No intervention | –Anesthesia performed without ultrasound |
| Ultrasound | Experimental | Device: UltrasoundAnesthesia performed after ultrasound |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Lumbar spinous processes impalpable. Elective caesarean delivery for singleton pregnancies BMI >30 No contraindications to neuraxial block Signed informed consent Neuraxial Block planned
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| UltrasoundUse of ultrasound to identify pre-puncture site | Device | Ultrasound |
Primary outcome
Needle movement
Time frame: 10 mins
number of needle redirections, defined as any ventral advancement of the needle and/or introducer, as well as any new intervertebral space attempted.
3 secondary outcomes
The insertion site identification time,
Time frame: 10 mins
Patient verbal numerical pain score (0-10) after skin incision.
Time frame: 10 mins
Patient verbal numerical pain score (0-10) after spinal performance. Patient verbal numerical pain score (0-10). Scale is Verbal numerical rating scale, where zero = no pain at all and 10 = maximum possible pain.
Time frame: 10 mins
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 5 Oct 2020.
- 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 Ultrasound in people with Ultrasound, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 1 inclusion and 0 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 5 Oct 2020. 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 Israel. 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 movement (time frame: 10 mins). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2020.