Injuries to the Ankle and FootNCT02571699
Minimum Effective Volume of Lidocaine-Bupivacaine for Subgluteal Block
A study testing Subgluteal Nerve Block in people with Injuries to the Ankle and Foot, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
The aim of this study is to determine the minimum effective volume of LA in 90 % of patients (MEV90) required for US-guided subgluteal sciatic nerve block. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Injuries to the Ankle and Foot
- What is being tested?
- Subgluteal Nerve Block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2016to Dec 2016
- 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
- American Society of Anesthesiologists classification 1-3
- body mass index between 20 and 35
Who cannot join
- adults who are unable to give their own consent
- pre-existing neuropathy (assessed by history and physical examination)
- coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets≤ 100, International Normalized Ratio≥ 1.4 or partial prothrombin time ≥ 50)
- renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
- hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
- allergy to LA
Show all 9Show fewer
- pregnancy
- prior surgery in the subgluteal region
- chronic pain syndromes requiring opioid intake at home
Trial locations and contacts
1 site in 1 country.
MontrealGH contact
Canada1 site, 1 recruiting
- Recruiting
Montreal General Hospital
Montreal, Quebec, H3G-1A4
De QH Tran, MD, FRCPC, +15149341934 ext. 43261, de_tran@hotmail.com
Roderick J Finlayson, MD, FRCPC
About this study
Official title: Minimum Effective Volume of Lidocaine-Bupivacaine for Ultrasound-Guided Subgluteal Sciatic Nerve Block
The aim of this study is to determine the minimum effective volume of LA in 90 % of patients (MEV90) required for US-guided subgluteal sciatic nerve block.
Read the detailed description
The aim of this study is to determine the minimum effective volume of LA in 90 % of patients (MEV90) required for US-guided subgluteal sciatic nerve block.
Success rate is defined as a minimal composite score of 6 points (out of 8 points) at 30 minutes.
- Conditions
- Injuries to the Ankle and Foot
- Being tested
- Subgluteal Nerve Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subgluteal Nerve BlockOther
ultrasound-guided subgluteal sciatic nerve block.
| Study group | Role | What they receive |
|---|---|---|
| Subgluteal sciatic block | Active comparator | Subgluteal block with similar volume Receives: Other: Subgluteal Nerve Block |
| Subgluteal block | Experimental | Subgluteal block with decreasing volume Receives: Other: Subgluteal Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate
minimal composite score of 6 out of 8 points
Measured: 0-30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study startMar 2016
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injuries to the Ankle and FootStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, De Tran, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- De Tran, MD, FRCPC, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02571699
- Sponsor's protocol ID
- MGH
- Status last verified
- Jun 2016
- First submitted
- 6 Oct 2015
- Last updated
- 13 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimum Effective Volume of Lidocaine-Bupivacaine for Ultrasound-Guided Subgluteal Sciatic Nerve Block
- ClinicalTrials.gov ID
- NCT02571699
- Acronym / sponsor ID
- MGH
- Conditions
- Injuries to the Ankle and Foot
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 8 Oct 2015 (estimated)
- 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 aim of this study is to determine the minimum effective volume of LA in 90 % of patients (MEV90) required for US-guided subgluteal sciatic nerve block.
Detailed description
The aim of this study is to determine the minimum effective volume of LA in 90 % of patients (MEV90) required for US-guided subgluteal sciatic nerve block.
Success rate is defined as a minimal composite score of 6 points (out of 8 points) at 30 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subgluteal sciatic block | Active comparator | Other: Subgluteal Nerve BlockSubgluteal block with similar volume |
| Subgluteal block | Experimental | Other: Subgluteal Nerve BlockSubgluteal block with decreasing volume |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age between 18 and 75 years
- American Society of Anesthesiologists classification 1-3
- body mass index between 20 and 35
Key exclusion criteria (9 listed)
- adults who are unable to give their own consent
- pre-existing neuropathy (assessed by history and physical examination)
- coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets≤ 100, International Normalized Ratio≥ 1.4 or partial prothrombin time ≥ 50)
- renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
- hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
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 |
|---|---|---|
| Subgluteal Nerve Blockultrasound-guided subgluteal sciatic nerve block. | Other | Subgluteal block, Subgluteal sciatic block |
Primary outcome
success rate
Time frame: 0-30 minutes
minimal composite score of 6 out of 8 points
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2016.
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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.
MontrealGH contact
De Tran, MD, FRCPC principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subgluteal Nerve Block in people with Injuries to the Ankle and Foot, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 13 Jun 2016. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MontrealGH, or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success rate (time frame: 0-30 minutes). 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 13 Jun 2016.