AnesthesiaNCT00802009
Dexamethasone and Analgesic Duration After Supraclavicular Brachial Plexus Blockade
A study testing Dexamethasone and Mepivicaine in people with Anesthesia, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Patients undergoing surgery of the hand often are treated with a nerve block in the shoulder/neck area that provides anesthesia/numbing during surgery. Nerve blocks usually last for a few hours after surgery and provide pain relief for this period. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Dexamethasone and Mepivicaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteCanada
- Study dates
- May 2009to Nov 2009
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients having unilateral hand or forearm surgery under Supraclavicular brachial plexus blockade.
- ASA I-III
- Age 18-60
- BMI < 35
Who cannot join
- Patients with a known history of hypersensitivity to local anesthetics and dexamethasone.
- Contra-indication to regional anesthesia/ supraclavicular brachial plexus blockade e.g. bleeding diathesis, coagulopathy.
- Peripheral neuropathy.
- Peptic ulcer disease.
- Diabetes Mellitus.
- Inability to give informed consent.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Toronto Western Hospital, University Health Network
Toronto, Ontario, M6G 2N6
About this study
Patients undergoing surgery of the hand often are treated with a nerve block in the shoulder/neck area that provides anesthesia/numbing during surgery. Nerve blocks usually last for a few hours after surgery and provide pain relief for this period. It may be possible to extend the duration of anesthesia by using a steroid, which has anti-inflammtory properties. This study will compare the duration of the nerve block when dexamethasone (steroid) is added to the anesthetic injected around the nerve.
- Conditions
- Anesthesia
- Being tested
- Dexamethasone, Mepivicaine
- Keywords
- ultrasound-guided regional anesthesia, nerve block, brachial plexus, mepivicaine, dexamethasone, hand wrist surgery, duration, anesthetic duration following brachial plexus/nerve block for hand/wrist surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Dexamethasone 8 milligrams (liquid) will be added to standard anesthetic solution administered during routine brachial plexus nerve blockade.
MepivicaineDrug
Standard anesthetic solution administered during routine brachial plexus nerve blockade.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Dexamethasone 8mg added to routine local anesthetic during brachial plexus blockade. Receives: Drug: Dexamethasone; Drug: Mepivicaine |
| 2 | Active comparator | Routine anesthetic solution (30 cc 1.5% mepivicaine) used during brachial plexus blockade. Receives: Drug: Mepivicaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of anesthesia
Measured: hourly for first 24 hours; daily until discharge
Secondary outcomes (1)
Requirements for pain medications; complications
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2008 (estimated)
- Study startMay 2009
- Primary completionOct 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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, Investigator
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00802009
- Sponsor's protocol ID
- 08-0896-B
- Status last verified
- Jan 2010
- First submitted
- 2 Dec 2008
- Last updated
- 26 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone and Analgesic Duration After Supraclavicular Brachial Plexus Blockade
- ClinicalTrials.gov ID
- NCT00802009
- Acronym / sponsor ID
- 08-0896-B
- Conditions
- Anesthesia
- Keywords
- ultrasound-guided regional anesthesia, nerve block, brachial plexus, mepivicaine, dexamethasone, hand wrist surgery, duration, anesthetic duration following brachial plexus/nerve block for hand/wrist surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 4 Dec 2008 (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 undergoing surgery of the hand often are treated with a nerve block in the shoulder/neck area that provides anesthesia/numbing during surgery. Nerve blocks usually last for a few hours after surgery and provide pain relief for this period. It may be possible to extend the duration of anesthesia by using a steroid, which has anti-inflammtory properties. This study will compare the duration of the nerve block when dexamethasone (steroid) is added to the anesthetic injected around the nerve.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Dexamethasone, Drug: MepivicaineDexamethasone 8mg added to routine local anesthetic during brachial plexus blockade. |
| 2 | Active comparator | Drug: MepivicaineRoutine anesthetic solution (30 cc 1.5% mepivicaine) used during brachial plexus blockade. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients having unilateral hand or forearm surgery under Supraclavicular brachial plexus blockade.
- ASA I-III
- Age 18-60
- BMI < 35
Key exclusion criteria (6 listed)
- Patients with a known history of hypersensitivity to local anesthetics and dexamethasone.
- Contra-indication to regional anesthesia/ supraclavicular brachial plexus blockade e.g. bleeding diathesis, coagulopathy.
- Peripheral neuropathy.
- Peptic ulcer disease.
- Diabetes Mellitus.
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 |
|---|---|---|
| DexamethasoneDexamethasone 8 milligrams (liquid) will be added to standard anesthetic solution administered during routine brachial plexus nerve blockade. | Drug | 1 |
| MepivicaineStandard anesthetic solution administered during routine brachial plexus nerve blockade. | Drug | 1, 2 |
Primary outcome
Duration of anesthesia
Time frame: hourly for first 24 hours; daily until discharge
1 secondary outcome
Requirements for pain medications; complications
Time frame: up to 3 months
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 26 Jan 2010.
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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 Dexamethasone and Mepivicaine in people with Anesthesia, run by University Health Network, Toronto 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 4 inclusion and 6 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 26 Jan 2010. 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?
Duration of anesthesia (time frame: hourly for first 24 hours; daily until discharge). 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 26 Jan 2010.