PainPhase 1/2NCT01986751
Effectiveness of Perineural Clonidine as an Adjuvant With Ropivacaine for Popliteal Nerve Block in Patients Undergoing Foot and Ankle Surgery
A Phase 1/2 study testing Clonidine and ropivacaine in people with Pain, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Nerve blocks are used to decrease the amount of pain you have after surgery. We are asking you to take part in a research study. This research study will test whether adding a medicine called clonidine to nerve blocks helps to improve them. Nerve blocks typically last less than a day after surgery. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Clonidine and ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Dec 2015
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient undergoing foot or ankle surgery with popliteal nerve block planned for postoperative analgesia.
- Adult, 19 years of age and older.
- Subject classified as American Society of Anesthesiology (ASA) class 1, 2, or 3. The ASA defines these statuses as follows: 1-A normal healthy patient. 2-A patient with mild systemic disease. 3-A patient with severe systemic disease.
- -
Who cannot join
- Any subject not classified as an ASA 1, 2, or 3.
- Allergy/intolerance to local anesthetic, clonidine, and/or oxycodone.
- Subject with a history of continuous opioid use for greater than one month prior to surgery.
- Pre-existing neurologic deficit in lower extremity (surgical site).
- Clinically significant coagulopathy (hemophilia, von Willebrand disease).
- Patients who fail to follow the UAB Department of Anesthesiology Algorithm for the Preoperative Management of an Angiotensin Converting Enzyme Inhibitor (ACEI) or an Angiotensin Receptor Blocker (ARB). A copy of the algorithm can be found in Appendix 1. -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
Nerve blocks are used to decrease the amount of pain you have after surgery. We are asking you to take part in a research study. This research study will test whether adding a medicine called clonidine to nerve blocks helps to improve them. Nerve blocks typically last less than a day after surgery. We are looking for ways to make them work better and last longer. Clonidine is approved for use as a blood pressure medicine. Its use in nerve blocks is investigational, but it may help nerve blocks to last longer. Adding clonidine to nerve blocks may also decrease the amount of pain medicine a person has after surgery. All people who enter this study will receive a nerve block with the normal medicine, but half of people will also have clonidine added to their nerve block. This study will enroll 60 participants from UAB hospitals.
- Conditions
- Pain
- Being tested
- Clonidine, ropivacaine
- Keywords
- nerve, block, motor blockade, lower extremity pain, nerve block
- Medical subject headings
- Pain, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClonidineDrug
Also called Catapres, Kapvay, Nexiclon, Jenloga, Duraclon
ropivacaineDrug
| Study group | Role | What they receive |
|---|---|---|
| Clonidine and Ropivacaine | Experimental | A bolus of 20 mL of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Receives: Drug: Clonidine; Drug: ropivacaine |
| Ropivacaine | Active comparator | Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine Receives: Drug: ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Time to Onset of Sensory and Motor Block Between the Study Group and the Control Group
Mean time onset of sensory block and motor block between the study group and the control group to assess the efficacy of clonidine to prolong the block duration.
Measured: baseline to 72 hours
Compare the Mean Duration of Sensory and/or Motor Block Between the Study Group and the Control Group
Mean duration of sensory and/or motor block between the study group and the control group to assess the efficacy of clonidine to prolong the block duration.
Measured: baseline to 72 hours
Secondary outcomes (6)
Compare the Mean VAS Scores at 24 Hours Post Procecure to Determine the Effectiveness of Perineural Clonidine on Duration of Postoperative Analgesia Between the Control Group and Study Group
The VAS score is measured as 0 - 10 with 0 being no pain to 10 being the worst pain imaginable to assess the efficacy of clonidine to control postoperative pain and patient satisfaction at the time of discharge.
Measured: baseline to 24 hours post block
Compare the Opioid Consumption During the First 24 Hours Between the Study Group and the Control Group
Mg equivalent of morphine consumption during the first 24 hours between the study group and the control group
Measured: baseline to 24 hours post block
Compare the Subjects Mean Arterial Blood Pressure Effect of Perineural Clonidine Versus Placebo
Comparing the mean arterial blood pressure between the study group and the control group to assess the effect of clonidine on blood pressure.
Measured: baseline to discharge from hospital (expected 3 days)
the Mean Time to Discharge After Start of Procedure for Each Group - Control and Study Group.
Comparing the mean hours from start of procedure to discharge between the study group and the control group
Measured: baseline to discharge (approximately 72 hours)
Mean Time to First Analgesic Intake Postoperative Between the Control Group and the Study Group.
Comparing the mean time to the first analgesic intake postoperative between the control group and the study group
Measured: baseline to 24 hours post block
Compare the Mean VAS Scores at 24 Hours Post Procedure to Determine the Patient Satisfaction on Duration of Postoperative Analgesia Between Control Group and Study Group
Compare the mean VAS scores at 24 hours between the study group and the control group to assess the efficacy of clonidine to control postoperative pain and patient satisfaction at the time of discharge.
Measured: baseline to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2013 (estimated)
- Study startJan 2014
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: failure to enroll
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Promil Kukreja, University of Alabama at Birmingham
- Investigators
- Promil Kukreja, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01986751
- Sponsor's protocol ID
- F130625002
- Status last verified
- Jul 2016
- First submitted
- 31 Oct 2013
- Last updated
- 4 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Perineural Clonidine as an Adjuvant With Ropivacaine for Popliteal Nerve Block in Patients Undergoing Foot and Ankle Surgery
- ClinicalTrials.gov ID
- NCT01986751
- Acronym / sponsor ID
- F130625002
- Conditions
- Pain
- Keywords
- nerve, block, motor blockade, lower extremity pain, nerve block
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: failure to enroll
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 18 Nov 2013 (estimated)
- Results
- Posted 4 Nov 2016
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 used to decrease the amount of pain you have after surgery. We are asking you to take part in a research study. This research study will test whether adding a medicine called clonidine to nerve blocks helps to improve them. Nerve blocks typically last less than a day after surgery. We are looking for ways to make them work better and last longer. Clonidine is approved for use as a blood pressure medicine. Its use in nerve blocks is investigational, but it may help nerve blocks to last longer. Adding clonidine to nerve blocks may also decrease the amount of pain medicine a person has after surgery. All people who enter this study will receive a nerve block with the normal medicine, but half of people will also have clonidine added to their nerve block. This study will enroll 60 participants from UAB hospitals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clonidine and Ropivacaine | Experimental | Drug: Clonidine, Drug: ropivacaineA bolus of 20 mL of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). |
| Ropivacaine | Active comparator | Drug: ropivacaineStandard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient undergoing foot or ankle surgery with popliteal nerve block planned for postoperative analgesia.
- Adult, 19 years of age and older.
- Subject classified as American Society of Anesthesiology (ASA) class 1, 2, or 3. The ASA defines these statuses as follows: 1-A normal healthy patient. 2-A patient with mild systemic disease. 3-A patient with severe systemic disease.
- -
Key exclusion criteria (6 listed)
- Any subject not classified as an ASA 1, 2, or 3.
- Allergy/intolerance to local anesthetic, clonidine, and/or oxycodone.
- Subject with a history of continuous opioid use for greater than one month prior to surgery.
- Pre-existing neurologic deficit in lower extremity (surgical site).
- Clinically significant coagulopathy (hemophilia, von Willebrand disease).
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 |
|---|---|---|
| ClonidineAlso: Catapres, Kapvay, Nexiclon, Jenloga, Duraclon | Drug | Clonidine and Ropivacaine |
| ropivacaine | Drug | Clonidine and Ropivacaine, Ropivacaine |
Primary outcome
Mean Time to Onset of Sensory and Motor Block Between the Study Group and the Control Group
Time frame: baseline to 72 hours
Mean time onset of sensory block and motor block between the study group and the control group to assess the efficacy of clonidine to prolong the block duration.
Compare the Mean Duration of Sensory and/or Motor Block Between the Study Group and the Control Group
Time frame: baseline to 72 hours
Mean duration of sensory and/or motor block between the study group and the control group to assess the efficacy of clonidine to prolong the block duration.
6 secondary outcomes
Compare the Mean VAS Scores at 24 Hours Post Procecure to Determine the Effectiveness of Perineural Clonidine on Duration of Postoperative Analgesia Between the Control Group and Study Group
Time frame: baseline to 24 hours post block
Compare the Opioid Consumption During the First 24 Hours Between the Study Group and the Control Group
Time frame: baseline to 24 hours post block
Compare the Subjects Mean Arterial Blood Pressure Effect of Perineural Clonidine Versus Placebo
Time frame: baseline to discharge from hospital (expected 3 days)
the Mean Time to Discharge After Start of Procedure for Each Group - Control and Study Group.
Time frame: baseline to discharge (approximately 72 hours)
Mean Time to First Analgesic Intake Postoperative Between the Control Group and the Study Group.
Time frame: baseline to 24 hours post block
Compare the Mean VAS Scores at 24 Hours Post Procedure to Determine the Patient Satisfaction on Duration of Postoperative Analgesia Between Control Group and Study Group
Time frame: baseline to 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Promil Kukreja, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Clonidine and ropivacaine in people with Pain, run by University of Alabama at Birmingham at 1 site in United States.
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: stopped early, as of the sponsor's last update on 4 Nov 2016. 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 United States. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 4 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Time to Onset of Sensory and Motor Block Between the Study Group and the Control Group (time frame: baseline to 72 hours). The study lists 2 primary outcomes in all. 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 4 Nov 2016.