PainNCT00523055
Ultrasound-guided Supraclavicular Brachial Plexus Blockade
A study testing Lidocaine in people with Pain, run by University of Manitoba at 1 site in Canada.
Trial summary
Pain Clinic patients undergoing physiotherapy for rehabilitation often have arm freezing performed. The quality of physiotherapy is felt to be superior with good pain control. The quality of the freezing is felt to be better when it is done with ultrasound guidance. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain
- What is being tested?
- Lidocaine
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- May 2008to Apr 2012
- 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
- patients undergoing brachial plexus anesthesia as part of disease management who have consented to participate in the study
Who cannot join
- Contraindication to brachial plexus anesthesia
- Informed consent not obtained
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-guided Supraclavicular Brachial Plexus Blockade: A Pharmacokinetic Study of Lidocaine and Adrenaline
Pain Clinic patients undergoing physiotherapy for rehabilitation often have arm freezing performed. The quality of physiotherapy is felt to be superior with good pain control. The quality of the freezing is felt to be better when it is done with ultrasound guidance. We are able to use less drug to achieve the same result. For this reason, we are doing a study to look at the level of freezing drug that accumulates in the body. We feel that the drug levels will be significantly different. We also feel that the time-to-peak drug level will be different than with traditional arm freezing procedures.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Lidocaine, 5 mg/kg, via needle placed adjacent to brachial plexus with ultrasound, dosing separated by 1 week, 2 doses in total, one block will contain 5 mcg/kg of adrenaline
What is being measured
The primary outcome is the main question the study is designed to answer.
Lidocaine drug level
Measured: 40 minutes
Secondary outcomes (2)
brachial plexus block quality
Measured: 30 minutes
Physiotherapy quality
Measured: within 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2007 (estimated)
- Study startMay 2008
- Primary completionApr 2012
Why it stopped: Clinical volume of patients for recruitment stopped.
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 PainStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric N Sutherland, MD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00523055
- Sponsor's protocol ID
- B2007:078
- Status last verified
- Apr 2011
- First submitted
- 28 Aug 2007
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Neal JM, Hebl JR, Gerancher JC, Hogan QH. Brachial plexus anesthesia: essentials of our current understanding. Reg Anesth Pain Med. 2002 Jul-Aug;27(4):402-28. doi: 10.1053/rapm.2002.34377. No abstract available.
PubMed 12132064Norder H, Hammas B, Larsen J, Skaug K, Magnius LO. Detection of HBV DNA by PCR in serum from an HBsAg negative blood donor implicated in cases of post-transfusion hepatitis B. Arch Virol Suppl. 1992;4:116-8. doi: 10.1007/978-3-7091-5633-9_24.
PubMed 1450678Soares LG, Brull R, Lai J, Chan VW. Eight ball, corner pocket: the optimal needle position for ultrasound-guided supraclavicular block. Reg Anesth Pain Med. 2007 Jan-Feb;32(1):94-5. doi: 10.1016/j.rapm.2006.10.007. No abstract available.
PubMed 17196502Beach ML, Sites BD, Gallagher JD. Use of a nerve stimulator does not improve the efficacy of ultrasound-guided supraclavicular nerve blocks. J Clin Anesth. 2006 Dec;18(8):580-4. doi: 10.1016/j.jclinane.2006.03.017.
PubMed 17175426
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Supraclavicular Brachial Plexus Blockade: A Pharmacokinetic Study of Lidocaine and Adrenaline
- ClinicalTrials.gov ID
- NCT00523055
- Acronym / sponsor ID
- B2007:078
- Conditions
- Pain
- Keywords
- Pain, Brachial Plexus Anesthesia, Plasma Lidocaine Levels, Ultrasound
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Clinical volume of patients for recruitment stopped.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Apr 2012 (actual)
- First posted
- 30 Aug 2007 (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.
Pain Clinic patients undergoing physiotherapy for rehabilitation often have arm freezing performed. The quality of physiotherapy is felt to be superior with good pain control. The quality of the freezing is felt to be better when it is done with ultrasound guidance. We are able to use less drug to achieve the same result. For this reason, we are doing a study to look at the level of freezing drug that accumulates in the body. We feel that the drug levels will be significantly different. We also feel that the time-to-peak drug level will be different than with traditional arm freezing procedures.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing brachial plexus anesthesia as part of disease management who have consented to participate in the study
Key exclusion criteria (2 listed)
- Contraindication to brachial plexus anesthesia
- Informed consent not obtained
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 |
|---|---|---|
| LidocaineLidocaine, 5 mg/kg, via needle placed adjacent to brachial plexus with ultrasound, dosing separated by 1 week, 2 doses in total, one block will contain 5 mcg/kg of adrenaline | Drug | – |
Primary outcome
Lidocaine drug level
Time frame: 40 minutes
2 secondary outcomes
brachial plexus block quality
Time frame: 30 minutes
Physiotherapy quality
Time frame: within 2 hours
Results and safety
The study was stopped early (reason given: Clinical volume of patients for recruitment stopped.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
- Background: PubMed 12132064Neal JM, Hebl JR, Gerancher JC, Hogan QH. Brachial plexus anesthesia: essentials of our current understanding. Reg Anesth Pain Med. 2002 Jul-Aug;27(4):402-28. doi: 10.1053/rapm.2002.34377. No abstract available.
- Background: PubMed 1450678Norder H, Hammas B, Larsen J, Skaug K, Magnius LO. Detection of HBV DNA by PCR in serum from an HBsAg negative blood donor implicated in cases of post-transfusion hepatitis B. Arch Virol Suppl. 1992;4:116-8. doi: 10.1007/978-3-7091-5633-9_24.
- Background: PubMed 17196502Soares LG, Brull R, Lai J, Chan VW. Eight ball, corner pocket: the optimal needle position for ultrasound-guided supraclavicular block. Reg Anesth Pain Med. 2007 Jan-Feb;32(1):94-5. doi: 10.1016/j.rapm.2006.10.007. No abstract available.
- Background: PubMed 17175426Beach ML, Sites BD, Gallagher JD. Use of a nerve stimulator does not improve the efficacy of ultrasound-guided supraclavicular nerve blocks. J Clin Anesth. 2006 Dec;18(8):580-4. doi: 10.1016/j.jclinane.2006.03.017.
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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.
Eric N Sutherland, MD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine in people with Pain, run by University of Manitoba 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 1 inclusion and 2 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: stopped early, as of the sponsor's last update on 10 May 2017. 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 was stopped early (reason given: Clinical volume of patients for recruitment stopped.). Results are not available in the source record.
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?
Lidocaine drug level (time frame: 40 minutes). 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 NCT00523055, 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 10 May 2017.