Infraclavicular Brachial Plexus BlockMEV90ROPINCT03824717
MEV 90 of 0.5% Ropivacaine In Infraclavicular Blocks
A study testing Dose of ropivacaine in people with Infraclavicular Brachial Plexus Block, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
Trial summary
Nerve blocks are routinely performed perioperatively to provide anesthesia and analgesia for various surgical procedures on the upper limb. These blocks are performed with the aid of an ultrasound machine to improve the success rate. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Infraclavicular Brachial Plexus Block
- What is being tested?
- Dose of ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- Jan 2019to Jun 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 80 years
- Amercian Society of Anesthesia physical status I, II, III
- Patients undergoing upper limb surgeries (with/without sedation)
- Ability to provide written informed consent
Who cannot join
- Patient refusal
- Known history of sensitivity or contraindications to study drugs
- Pregnant patients
- Infection at the site of administration of block
- Significant blood coagulation disorders
- Neurological deficits involving brachial plexus
- Patients on any medication which is known to have drug interactions with the study drugs
- Patients who receive general anesthesia/ narcotic supplements
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Minimum Effective Volume of 0.5% Ropivacaine for Ultrasound-Guided Infraclavicular Block
Nerve blocks are routinely performed perioperatively to provide anesthesia and analgesia for various surgical procedures on the upper limb. These blocks are performed with the aid of an ultrasound machine to improve the success rate. Below the clavicle approach to these nerves is used for surgeries below the elbow, forearm and hand efficiently.
Ultrasound guidance for such blocks allows direct visualisation of the needle and the spread of the freezing medication (local anesthetic) in real-time therefore reducing complications and improving success rates of blocks. It may be possible that a smaller volume of local anesthetic in this setting may allow effective anesthesia while lowering the adverse effects. The aim of this study is to find out the lowest volume of the local anesthetic that will be effective in blocking the nerves adequately.
Read the detailed description
This is a dose finding study. Volume assignment of ropivacaine will be carried out using a Biased Coin Design up and down method. In this method, the volume of local anesthetic (ropivacaine) administered to each patient will depends on the response of the previous patient. In the event of block failure, the next subject will receive an additional 2 mL of volume compared with the previous patient. In the event of block success, the next patient will receive either the same volume as the last patient or a 2 mL reduction in volume (per the biased coin design with a probability of the same volume being 0.9 and lower volume being 0.1). The first patient in the study will receive 30 mL and depending on the block success, the volume of the next block will be increased or decreased. The biased coin design is well described and established in other minimum volume studies.
All patients will have the block in the block room with standard monitoring (non-invasive blood pressure, pulse-oximetry, electrocardiogram) and mild sedation with midazolam and fentanyl. All blocks will be performed by staff anesthesiologists with a subspecialty in regional anesthesia and who work routinely in the block room or by a resident or fellow who is directly supervised by one of these staff anesthesiologist.
There will be two follow up telephone call to all patients enrolled in this study 24 hours post block insertion and one at 7 days to discuss length of block duration, any postoperative nausea/vomiting, any ongoing numbness or tingling, and overall satisfaction with the block. The participants will be informed of this phone call as part of the consent process and their telephone number will be confirmed.
- Conditions
- Infraclavicular Brachial Plexus Block
- Being tested
- Dose of ropivacaine
- Keywords
- Ropivacaine, Brachial plexus block, Infraclavicular block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose of ropivacaineDrug
Biased coin design up and down dose finding study of 0.5% ropivacaine to achieve a successful infraclavicular brachial plexus block
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine dosage | Other | Dose finding study - The volume of 0.5% ropivacaine used to achieve surgical anesthesia in infraclavicular brachial plexus block Receives: Drug: Dose of ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
ED90 of 0.5% Ropivacaine
Volume used to achieve sensory and motor blockade (surgical anesthesia)
Measured: 30 minutes
Secondary outcomes (1)
Surgical anesthesia
Sensory and motor blockade tested using pin prick sensation ( 0 - normal sensation and can feel pin-prick, 1 - touch only, 2 - no sensation of touch or pinprick) and motor function of the ulnar, radial and median nerves.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study startJan 2019 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infraclavicular Brachial Plexus BlockStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Biased coin design and up and down method to determine the minimum effective volume of Ropivacaine in ultrasound guided infraclavicular brachial plexus blocks.
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03824717
- Sponsor's protocol ID
- 112062
- Acronym
- MEV90ROPI
- Status last verified
- Jan 2019
- First submitted
- 9 Jan 2019
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimum Effective Volume of 0.5% Ropivacaine for Ultrasound-Guided Infraclavicular Block
- ClinicalTrials.gov ID
- NCT03824717
- Acronym / sponsor ID
- MEV90ROPI / 112062
- Conditions
- Infraclavicular Brachial Plexus Block
- Keywords
- Ropivacaine, Brachial plexus block, Infraclavicular block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Jan 2019 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 31 Jan 2019 (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.
Nerve blocks are routinely performed perioperatively to provide anesthesia and analgesia for various surgical procedures on the upper limb. These blocks are performed with the aid of an ultrasound machine to improve the success rate. Below the clavicle approach to these nerves is used for surgeries below the elbow, forearm and hand efficiently.
Ultrasound guidance for such blocks allows direct visualisation of the needle and the spread of the freezing medication (local anesthetic) in real-time therefore reducing complications and improving success rates of blocks. It may be possible that a smaller volume of local anesthetic in this setting may allow effective anesthesia while lowering the adverse effects. The aim of this study is to find out the lowest volume of the local anesthetic that will be effective in blocking the nerves adequately.
Detailed description
This is a dose finding study. Volume assignment of ropivacaine will be carried out using a Biased Coin Design up and down method. In this method, the volume of local anesthetic (ropivacaine) administered to each patient will depends on the response of the previous patient. In the event of block failure, the next subject will receive an additional 2 mL of volume compared with the previous patient. In the event of block success, the next patient will receive either the same volume as the last patient or a 2 mL reduction in volume (per the biased coin design with a probability of the same volume being 0.9 and lower volume being 0.1). The first patient in the study will receive 30 mL and depending on the block success, the volume of the next block will be increased or decreased. The biased coin design is well described and established in other minimum volume studies.
All patients will have the block in the block room with standard monitoring (non-invasive blood pressure, pulse-oximetry, electrocardiogram) and mild sedation with midazolam and fentanyl. All blocks will be performed by staff anesthesiologists with a subspecialty in regional anesthesia and who work routinely in the block room or by a resident or fellow who is directly supervised by one of these staff anesthesiologist.
There will be two follow up telephone call to all patients enrolled in this study 24 hours post block insertion and one at 7 days to discuss length of block duration, any postoperative nausea/vomiting, any ongoing numbness or tingling, and overall satisfaction with the block. The participants will be informed of this phone call as part of the consent process and their telephone number will be confirmed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Biased coin design and up and down method to determine the minimum effective volume of Ropivacaine in ultrasound guided infraclavicular brachial plexus blocks.
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine dosage | Other | Drug: Dose of ropivacaineDose finding study - The volume of 0.5% ropivacaine used to achieve surgical anesthesia in infraclavicular brachial plexus block |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 to 80 years
- Amercian Society of Anesthesia physical status I, II, III
- Patients undergoing upper limb surgeries (with/without sedation)
- Ability to provide written informed consent
Key exclusion criteria (8 listed)
- Patient refusal
- Known history of sensitivity or contraindications to study drugs
- Pregnant patients
- Infection at the site of administration of block
- Significant blood coagulation disorders
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 |
|---|---|---|
| Dose of ropivacaineBiased coin design up and down dose finding study of 0.5% ropivacaine to achieve a successful infraclavicular brachial plexus block | Drug | Ropivacaine dosage |
Primary outcome
ED90 of 0.5% Ropivacaine
Time frame: 30 minutes
Volume used to achieve sensory and motor blockade (surgical anesthesia)
1 secondary outcome
Surgical anesthesia
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Dose of ropivacaine in people with Infraclavicular Brachial Plexus Block, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
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 4 inclusion and 8 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 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Shalini Dhir, MD, FRCPC (+1 519 646 6000 ext. 64219, shalini.dhir@sjhc.london.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ED90 of 0.5% Ropivacaine (time frame: 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 31 Jan 2019.