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failure to enroll
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Ropivacaine | Active Comparator | Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clonidine | Drug |
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| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | baseline to 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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.
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Promil Kukreja, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Clonidine and Ropivacaine | 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). Clonidine ropivacaine |
| FG001 | Ropivacaine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| ropivacaine |
| Drug |
|
| 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 | 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. | 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 | 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 | 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. | baseline to 24 hours |
Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine ropivacaine |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Clonidine and Ropivacaine | 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). Clonidine ropivacaine |
| BG001 | Ropivacaine | Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine ropivacaine |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Study was prematurely terminated. No data were collected for this assessment. | Posted | baseline to 72 hours |
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| ||||||||||||||||||||||
| Primary | 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. | Study was prematurely terminated. No data were collected for this assessment | Posted | baseline to 72 hours |
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| Secondary | 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. | Study was prematurely terminated. No data were collected for this assessment | Posted | baseline to 24 hours post block |
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| Secondary | 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 | Study was prematurely terminated. No data were collected for this assessment | Posted | baseline to 24 hours post block |
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| ||||||||||||||||||||||
| Secondary | 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. | Study was prematurely terminated. No data were collected for this assessment | Posted | baseline to discharge from hospital (expected 3 days) |
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| ||||||||||||||||||||||
| Secondary | 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 | Study was prematurely terminated. No data were collected for this assessment | Posted | baseline to discharge (approximately 72 hours) |
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| Secondary | 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 | Study was prematurely terminated. No data were collected for this assessment | Posted | baseline to 24 hours post block |
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| Secondary | 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. | Study was prematurely terminated. No data were collected for this assessment | Posted | baseline to 24 hours |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Clonidine and Ropivacaine (Study Group) | 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). | 0 | 10 | 0 | 10 | ||
| EG001 | Ropivacaine (Control) | Standard saphenous nerve block (adductor canal approach) will be performed using 20 ml of 0.5% ropivacaine | 0 | 4 | 0 | 4 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Promil Kukreja | University of Alabama Birmingham | 205-996-7025 | pkukreja@uabmc.edu |
| ID | Term |
|---|---|
| D010146 | Pain |
| D001733 | Bites and Stings |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D003000 | Clonidine |
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participants |
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