Spinal AnaesthesiaNCT01699373
A Trial on Ultrasound-assisted Spinal Anaesthesia
A study testing Ultrasound scan in people with Spinal Anaesthesia and Ultrasound, run by Changi General Hospital at 1 site in Singapore.
Trial summary
A randomised controlled trial comparing the use of pre-procedural ultrasound scanning with manual palpation to identify landmarks for performance of spinal anaesthesia. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Spinal Anaesthesia, Ultrasound
- What is being tested?
- Ultrasound scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteSingapore
- Study dates
- Apr 2011to May 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I to III
- undergoing surgery amenable to spinal anaesthesia
Who cannot join
- Patient refusal
- contraindications to regional anaesthesia
- known allergy to local anaesthetics
- bleeding diathesis
- inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Trial on Ultrasound-assisted Spinal Anaesthesia
A randomised controlled trial comparing the use of pre-procedural ultrasound scanning with manual palpation to identify landmarks for performance of spinal anaesthesia.
- Conditions
- Spinal Anaesthesia, Ultrasound
- Being tested
- Ultrasound scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound scanProcedure or surgery
Pre-procedural ultrasound scan was performed
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-assisted | Experimental | Pre-procedural ultrasound scan performed Receives: Procedure: Ultrasound scan |
| Manual Palpation | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate of First-attempt of Spinal Anaesthesia
Measured: During procedure
Secondary outcomes (1)
Time Taken to Perform Spinal Anaesthesia
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2012 (estimated)
- Study startApr 2011
- Primary completionApr 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spinal AnaesthesiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01699373
- Sponsor's protocol ID
- UGSA/2010
- Status last verified
- Feb 2013
- First submitted
- 30 Sep 2012
- Last updated
- 9 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial on Ultrasound-assisted Spinal Anaesthesia
- ClinicalTrials.gov ID
- NCT01699373
- Acronym / sponsor ID
- UGSA/2010
- Conditions
- Spinal Anaesthesia, Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 3 Oct 2012 (estimated)
- Results
- Posted 9 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomised controlled trial comparing the use of pre-procedural ultrasound scanning with manual palpation to identify landmarks for performance of spinal anaesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-assisted | Experimental | Procedure: Ultrasound scanPre-procedural ultrasound scan performed |
| Manual Palpation | No intervention | – |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA I to III
- undergoing surgery amenable to spinal anaesthesia
Key exclusion criteria (5 listed)
- Patient refusal
- contraindications to regional anaesthesia
- known allergy to local anaesthetics
- bleeding diathesis
- inability to provide informed consent
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 |
|---|---|---|
| Ultrasound scanPre-procedural ultrasound scan was performed | Procedure or surgery | Ultrasound-assisted |
Primary outcome
Success Rate of First-attempt of Spinal Anaesthesia
Time frame: During procedure
1 secondary outcome
Time Taken to Perform Spinal Anaesthesia
Time frame: During procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 scan in people with Spinal Anaesthesia and Ultrasound, run by Changi General Hospital at 1 site in Singapore.
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 2 inclusion and 5 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 9 Apr 2013. 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 Singapore. 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?
Yes. Results are posted in the registry (first posted 9 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Success Rate of First-attempt of Spinal Anaesthesia (time frame: During procedure). 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 9 Apr 2013.