Fascicular BlockPhase 2NCT01620112
The Effects of Different Clonidine Concentrations on Axillary Brachial Plexus Block With 1,5% Lidocaine
A Phase 2 study testing high Clonidine concentration, low clonidine concentration and Lidocaine in people with Fascicular Block and Motor Activity, run by Universidade Federal do Rio de Janeiro.
Trial summary
The purpose of this study is to determine whether different clonidine concentration on axillary brachial plexus block with 1,5% lidocaine for upper limb surgery may influence the sensory and motor block onset time and duration, postoperative analgesia duration, postoperative pain intensity Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fascicular Block, Motor Activity, Pain, Postoperative
- What is being tested?
- high Clonidine concentration, low clonidine concentration and Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Feb 2009to Jul 2011
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- both genders,
- over 18 years old,
- American Society of Anesthesiologists (ASA) 1 to 3
Who cannot join
- patients with chronic use of analgesics and non-steroidal anti-inflammatories drugs,
- pregnant,
- with infection at the puncture site,
- coagulopathies or intolerance to drugs used in the study
About this study
Official title: The Effects of Different Clonidine Concentrations on Axillary Brachial Plexus Block With 1,5% Lidocaine for Upper Limb Surgery: a Prospective Randomized Study
The purpose of this study is to determine whether different clonidine concentration on axillary brachial plexus block with 1,5% lidocaine for upper limb surgery may influence the sensory and motor block onset time and duration, postoperative analgesia duration, postoperative pain intensity
Read the detailed description
Brachial plexus blocks are frequently used in surgical procedures involving the upper limb because they facilitate surgical anaesthesia, muscle relaxation and post-operative analgesics.
Various drugs are used to supplement local anaesthetics during brachial plexus block. Many studies in the literature show that clonidine, which is an alpha-2 agonist, prolongs the length of anesthesia and post-operative analgesia.4,5 However, clonidine's side effects-such as hypotension, bradycardia and sedation can limit its use.
There are no studies comparing different clonidine concentrations on the axillary brachial block, so the hypothesis of the present study was that different clonidine concentrations and LA volumes may influence the anaesthesia and analgesia quality on this type of regional block.
- Conditions
- Fascicular Block, Motor Activity, Pain, Postoperative, Latency Period
- Being tested
- high Clonidine concentration, low clonidine concentration, Lidocaine, Lidocaine 40 ml
- Keywords
- brachial plexus, lidocaine, alfa 2 adrenergic receptor clonidine, orthopedic procedure
- Medical subject headings
- Bundle-Branch Block, Motor Activity, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high Clonidine concentrationDrug
Clonidine 1 ml - 150 mcg on 20 ml de lidocaine 1,5% on axillary brachial plexus block for upper limb surgery
low clonidine concentrationDrug
Clonidine 1 ml - 150 mcg on 40 ml of lidocaine 1,5% - single injection on axillary brachial plexus block for upper limb
LidocaineDrug
Lidocaine 1,5% 20 ml 300 mg for single injection on axillary brachial plexus block for upper lim surgery
Lidocaine 40 mlDrug
Lidocaine 40 ml 1,5% 600 mg single injection for axillary brachial plexus block for upper limb surgery
| Study group | Role | What they receive |
|---|---|---|
| low clonidine concentration | Active comparator | clonidine concentration 1 ml on 40 ml of lidocaine 1.5% for upper brachial plexus Receives: Drug: low clonidine concentration |
| lidocaine 20 ml 1,5% | Active comparator | lidocaine 20 ml 1,5% without clonidine for axillary brachial plexus block for upper limb surgery Receives: Drug: Lidocaine |
| high clonidine concentration | Active comparator | clonidine concentration 150 mcg on 20 ml of lidocaine 1,5% for upper brachial plexus Receives: Drug: high Clonidine concentration |
| 40 ml lidocaine 1,5% | Active comparator | 40 ml of lidocaine 1,5% without clonidine for upper brachial plexus Receives: Drug: Lidocaine 40 ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensorial and motor block duration
to compare two concentrations of clonidine on different volumes of lidocaine, in terms of sensorial and motor block duration
Measured: 24 hours after surgery
Secondary outcomes (4)
adverse effects of additive clonidine on axillary brachial plexus block in upper limb surgery
analyse the adverse effects of additive clonidine on axillary brachial plexus block in upper limb surgery
Measured: 24 hours after surgery
postoperative analgesia duration
to compare two concentrations of clonidine on different volumes of lidocaine, in terms of postoperative analgesia duration
Measured: 24 hours
sensorial and motor block onset time
to compare two concentrations of clonidine on different volumes of lidocaine, in terms of sensorial and motor block onset time
Measured: 24 hours
postoperative pain intensity
to compare two concentrations of clonidine on different volumes of lidocaine, in terms postoperative pain intensity
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2012 (estimated)
- Study startFeb 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fascicular BlockStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandra Rezende Assad, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01620112
- Sponsor's protocol ID
- 090/2002
- Status last verified
- Jun 2012
- First submitted
- 9 Jun 2012
- Last updated
- 15 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Different Clonidine Concentrations on Axillary Brachial Plexus Block With 1,5% Lidocaine for Upper Limb Surgery: a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT01620112
- Acronym / sponsor ID
- 090/2002
- Conditions
- Fascicular Block, Motor Activity, Pain, Postoperative, Latency Period
- Keywords
- brachial plexus, lidocaine, alfa 2 adrenergic receptor clonidine, orthopedic procedure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 15 Jun 2012 (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 purpose of this study is to determine whether different clonidine concentration on axillary brachial plexus block with 1,5% lidocaine for upper limb surgery may influence the sensory and motor block onset time and duration, postoperative analgesia duration, postoperative pain intensity
Detailed description
Brachial plexus blocks are frequently used in surgical procedures involving the upper limb because they facilitate surgical anaesthesia, muscle relaxation and post-operative analgesics.
Various drugs are used to supplement local anaesthetics during brachial plexus block. Many studies in the literature show that clonidine, which is an alpha-2 agonist, prolongs the length of anesthesia and post-operative analgesia.4,5 However, clonidine's side effects-such as hypotension, bradycardia and sedation can limit its use.
There are no studies comparing different clonidine concentrations on the axillary brachial block, so the hypothesis of the present study was that different clonidine concentrations and LA volumes may influence the anaesthesia and analgesia quality on this type of regional block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| low clonidine concentration | Active comparator | Drug: low clonidine concentrationclonidine concentration 1 ml on 40 ml of lidocaine 1.5% for upper brachial plexus |
| lidocaine 20 ml 1,5% | Active comparator | Drug: Lidocainelidocaine 20 ml 1,5% without clonidine for axillary brachial plexus block for upper limb surgery |
| high clonidine concentration | Active comparator | Drug: high Clonidine concentrationclonidine concentration 150 mcg on 20 ml of lidocaine 1,5% for upper brachial plexus |
| 40 ml lidocaine 1,5% | Active comparator | Drug: Lidocaine 40 ml40 ml of lidocaine 1,5% without clonidine for upper brachial plexus |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- both genders,
- over 18 years old,
- American Society of Anesthesiologists (ASA) 1 to 3
Key exclusion criteria (4 listed)
- patients with chronic use of analgesics and non-steroidal anti-inflammatories drugs,
- pregnant,
- with infection at the puncture site,
- coagulopathies or intolerance to drugs used in the study
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 |
|---|---|---|
| high Clonidine concentrationClonidine 1 ml - 150 mcg on 20 ml de lidocaine 1,5% on axillary brachial plexus block for upper limb surgery | Drug | high clonidine concentration |
| low clonidine concentrationClonidine 1 ml - 150 mcg on 40 ml of lidocaine 1,5% - single injection on axillary brachial plexus block for upper limb | Drug | low clonidine concentration |
| LidocaineLidocaine 1,5% 20 ml 300 mg for single injection on axillary brachial plexus block for upper lim surgery | Drug | lidocaine 20 ml 1,5% |
| Lidocaine 40 mlLidocaine 40 ml 1,5% 600 mg single injection for axillary brachial plexus block for upper limb surgery | Drug | 40 ml lidocaine 1,5% |
Primary outcome
sensorial and motor block duration
Time frame: 24 hours after surgery
to compare two concentrations of clonidine on different volumes of lidocaine, in terms of sensorial and motor block duration
4 secondary outcomes
adverse effects of additive clonidine on axillary brachial plexus block in upper limb surgery
Time frame: 24 hours after surgery
postoperative analgesia duration
Time frame: 24 hours
sensorial and motor block onset time
Time frame: 24 hours
postoperative pain intensity
Time frame: 24 hours
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 15 Jun 2012.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing high Clonidine concentration, low clonidine concentration and Lidocaine in people with Fascicular Block and Motor Activity, run by Universidade Federal do Rio de Janeiro.
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 4 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 15 Jun 2012. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
sensorial and motor block duration (time frame: 24 hours after surgery). 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 15 Jun 2012.