Upper Limb InjuryCPINCT02657291
Costoclavicular vs Paracoracoid Approach to Infraclavicular Brachial Plexus Block: a Feasibility Study
A study testing Ropivacaine and Ultrasound in people with Upper Limb Injury, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Patients for upper limb surgeries who are candidates for infraclavicular block will be screened. Two techniques of infraclavicular block will be compared. Measured outcomes are performance times, block onset times, patient satisfaction, quality of block, and requirement for supplementary analgesia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Upper Limb Injury
- What is being tested?
- Ropivacaine and Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2015to Dec 2017
- 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
- Ambulatory elective surgery of the upper limb
- ASA (American Society of Anesthesiologists physical status classification system) 1-4
- Suitable for procedure to be carried out under infraclavicular block
Who cannot join
- Inability to give informed consent, Allergy to local anesthetics, morphine or fentanyl
- Ongoing major medical or psychiatric problems
- Narcotic abuse
- Peripheral neuropathy or major neurological problems
- Scarring in area of blockade
- Inability to co-operate with post-operative evaluation
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- Major coagulopathy
- Pregnancy and breast-feeding
- Women of childbearing age who are not taking adequate contraceptive precautions
Trial locations and contacts
1 site in 1 country.
About this study
Patients for upper limb surgeries who are candidates for infraclavicular block will be screened. Two techniques of infraclavicular block will be compared. Measured outcomes are performance times, block onset times, patient satisfaction, quality of block, and requirement for supplementary analgesia.
Read the detailed description
Infraclavicular brachial plexus block under ultrasound guidance is used for surgeries on the upper limb. Traditionally, the block is performed at the lateral infraclavicular fossa where the cords are variable in position relative to the axillary artery. A recently introduced technique is the costoclavicular approach where the cords are viewed as relatively more superficial and clustered together compared to the traditional technique. Those meeting the inclusion criteria and will consent to participate in the study will be randomized to have either an infraclavicular block in the paracoracoid approach (Group 1) or an infraclavicular block in the costoclavicular approach (Group 2). All groups will have the same injectable volume (35 mls) and local anesthetic concentration (ropivacaine 0.5%). There will be 35 study patients for each group for a total of 70 patients.
- Conditions
- Upper Limb Injury
- Being tested
- Ropivacaine, Ultrasound
- Medical subject headings
- Arm Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Also called Naropin
Local anesthetic
UltrasoundDevice
Ultrasound guided block
| Study group | Role | What they receive |
|---|---|---|
| Costoclavicular | Experimental | Ultrasound-guided infraclavicular block using Ropivacaine 0.5% 35 mL using the costoclavicular approach Receives: Drug: Ropivacaine; Device: Ultrasound |
| Paracoracoid | Active comparator | Ultrasound-guided infraclavicular block using Ropivacaine 0.5% 35 mL using the paracoracoid or standard approach Receives: Drug: Ropivacaine; Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Block onset time
From the time needle is removed from the patient's skin up to the time when block is considered adequate for surgery
Measured: 1 hour
Secondary outcomes (4)
Procedure duration
From the time the US probe touches the skin to the time the needle is removed
Measured: 1 hour
Quality of block
Measured: 1 hour
Patient satisfaction
Satisfaction score (VAS ranging from 0 = completely dissatisfied to 10 = completely satisfied)
Measured: 1 day
Requirement for supplemental analgesia or anesthesia
Quality of block will be assessed if adequate for surgery
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Upper Limb InjuryStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
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
- Principal investigator, Shalini Dhir, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Shalini Dhir, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02657291
- Sponsor's protocol ID
- LawsonHRI
- Acronym
- CPI
- Status last verified
- Jan 2021
- First submitted
- 10 Dec 2015
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Karmakar MK, Sala-Blanch X, Songthamwat B, Tsui BC. Benefits of the costoclavicular space for ultrasound-guided infraclavicular brachial plexus block: description of a costoclavicular approach. Reg Anesth Pain Med. 2015 May-Jun;40(3):287-8. doi: 10.1097/AAP.0000000000000232. No abstract available.
PubMed 25899958Bigeleisen P, Wilson M. A comparison of two techniques for ultrasound guided infraclavicular block. Br J Anaesth. 2006 Apr;96(4):502-7. doi: 10.1093/bja/ael024. Epub 2006 Feb 24.
PubMed 16500953Mosaffa F, Gharaei B, Rafeeyan M, Gachkar L. Comparing vertical and coracoid approaches for infraclavicular block in orthopedic surgery of the forearm and hand. J Clin Anesth. 2012 May;24(3):196-200. doi: 10.1016/j.jclinane.2011.07.013. Epub 2012 Apr 5.
PubMed 22484026Acar S, Gurkan Y, Solak M, Toker K. Coracoid versus lateral sagittal infraclavicular block. Acta Orthop Traumatol Turc. 2013;47(1):32-7. doi: 10.3944/aott.2013.2615.
PubMed 23549315
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Costoclavicular vs Paracoracoid Approach to Infraclavicular Brachial Plexus Block: a Feasibility Study
- ClinicalTrials.gov ID
- NCT02657291
- Acronym / sponsor ID
- CPI / LawsonHRI
- Conditions
- Upper Limb Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 15 Jan 2016 (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.
Patients for upper limb surgeries who are candidates for infraclavicular block will be screened. Two techniques of infraclavicular block will be compared. Measured outcomes are performance times, block onset times, patient satisfaction, quality of block, and requirement for supplementary analgesia.
Detailed description
Infraclavicular brachial plexus block under ultrasound guidance is used for surgeries on the upper limb. Traditionally, the block is performed at the lateral infraclavicular fossa where the cords are variable in position relative to the axillary artery. A recently introduced technique is the costoclavicular approach where the cords are viewed as relatively more superficial and clustered together compared to the traditional technique. Those meeting the inclusion criteria and will consent to participate in the study will be randomized to have either an infraclavicular block in the paracoracoid approach (Group 1) or an infraclavicular block in the costoclavicular approach (Group 2). All groups will have the same injectable volume (35 mls) and local anesthetic concentration (ropivacaine 0.5%). There will be 35 study patients for each group for a total of 70 patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Costoclavicular | Experimental | Drug: Ropivacaine, Device: UltrasoundUltrasound-guided infraclavicular block using Ropivacaine 0.5% 35 mL using the costoclavicular approach |
| Paracoracoid | Active comparator | Drug: Ropivacaine, Device: UltrasoundUltrasound-guided infraclavicular block using Ropivacaine 0.5% 35 mL using the paracoracoid or standard approach |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ambulatory elective surgery of the upper limb
- ASA (American Society of Anesthesiologists physical status classification system) 1-4
- Suitable for procedure to be carried out under infraclavicular block
Key exclusion criteria (9 listed)
- Inability to give informed consent, Allergy to local anesthetics, morphine or fentanyl
- Ongoing major medical or psychiatric problems
- Narcotic abuse
- Peripheral neuropathy or major neurological problems
- Scarring in area of blockade
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 |
|---|---|---|
| RopivacaineAlso: NaropinLocal anesthetic | Drug | Costoclavicular, Paracoracoid |
| UltrasoundUltrasound guided block | Device | Costoclavicular, Paracoracoid |
Primary outcome
Block onset time
Time frame: 1 hour
From the time needle is removed from the patient's skin up to the time when block is considered adequate for surgery
4 secondary outcomes
Procedure duration
Time frame: 1 hour
Quality of block
Time frame: 1 hour
Patient satisfaction
Time frame: 1 day
Requirement for supplemental analgesia or anesthesia
Time frame: 1 day
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 20 Jan 2021.
- Background: PubMed 25899958Karmakar MK, Sala-Blanch X, Songthamwat B, Tsui BC. Benefits of the costoclavicular space for ultrasound-guided infraclavicular brachial plexus block: description of a costoclavicular approach. Reg Anesth Pain Med. 2015 May-Jun;40(3):287-8. doi: 10.1097/AAP.0000000000000232. No abstract available.
- Background: PubMed 16500953Bigeleisen P, Wilson M. A comparison of two techniques for ultrasound guided infraclavicular block. Br J Anaesth. 2006 Apr;96(4):502-7. doi: 10.1093/bja/ael024. Epub 2006 Feb 24.
- Background: PubMed 22484026Mosaffa F, Gharaei B, Rafeeyan M, Gachkar L. Comparing vertical and coracoid approaches for infraclavicular block in orthopedic surgery of the forearm and hand. J Clin Anesth. 2012 May;24(3):196-200. doi: 10.1016/j.jclinane.2011.07.013. Epub 2012 Apr 5.
- Background: PubMed 23549315Acar S, Gurkan Y, Solak M, Toker K. Coracoid versus lateral sagittal infraclavicular block. Acta Orthop Traumatol Turc. 2013;47(1):32-7. doi: 10.3944/aott.2013.2615.
- Individual participant dataSharing planned: Undecided
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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.
Shalini Dhir principal investigator
Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine and Ultrasound in people with Upper Limb Injury, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's 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: finished, as of the sponsor's last update on 20 Jan 2021. 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?
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?
Block onset time (time frame: 1 hour). 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 NCT02657291, which also lists 4 linked publications.
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 20 Jan 2021.