Pain
Conditions
Keywords
nerve, block, motor blockade, lower extremity pain, nerve block
Brief 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. 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.
Interventions
DRUGClonidine
DRUGropivacaine
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient undergoing foot or ankle surgery with popliteal nerve block planned for postoperative analgesia. 2. Adult, 19 years of age and older. 3. 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. \-
Exclusion criteria
1. Any subject not classified as an ASA 1, 2, or 3. 2. Allergy/intolerance to local anesthetic, clonidine, and/or oxycodone. 3. Subject with a history of continuous opioid use for greater than one month prior to surgery. 4. Pre-existing neurologic deficit in lower extremity (surgical site). 5. Clinically significant coagulopathy (hemophilia, von Willebrand disease). 6. 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. -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Time to Onset of Sensory and Motor Block Between the Study Group and the Control Group | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare the Subjects Mean Arterial Blood Pressure Effect of Perineural Clonidine Versus Placebo | baseline to discharge from hospital (expected 3 days) | Comparing the mean arterial blood pressure between the study group and the control group to assess the effect of clonidine on blood pressure. |
| the Mean Time to Discharge After Start of Procedure for Each Group - Control and Study Group. | baseline to discharge (approximately 72 hours) | Comparing the mean hours from start of procedure to discharge between the study group and the control group |
| 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 | baseline to 24 hours post block | 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. |
| 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 | baseline to 24 hours | 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. |
| Mean Time to First Analgesic Intake Postoperative Between the Control Group and the Study Group. | baseline to 24 hours post block | Comparing the mean time to the first analgesic intake postoperative between the control group and the study group |
| Compare the Opioid Consumption During the First 24 Hours Between the Study Group and the Control Group | baseline to 24 hours post block | Mg equivalent of morphine consumption during the first 24 hours between the study group and the control group |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 10 |
| Ropivacaine Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine
ropivacaine | 4 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | improperly consented | 10 | 2 |
Baseline characteristics
| Characteristic | Clonidine and Ropivacaine | Ropivacaine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 4 Participants | 14 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants | 4 Participants | 14 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 10 participants | 4 participants | 14 participants |
| Sex: Female, Male Female | 6 Participants | 3 Participants | 9 Participants |
| Sex: Female, Male Male | 4 Participants | 1 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 4 |
| serious Total, serious adverse events | 0 / 10 | 0 / 4 |
Outcome results
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.
Time frame: baseline to 72 hours
Population: Study was prematurely terminated. No data were collected for this assessment
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.
Time frame: baseline to 72 hours
Population: Study was prematurely terminated. No data were collected for this assessment.
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.
Time frame: baseline to 24 hours post block
Population: Study was prematurely terminated. No data were collected for this assessment
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.
Time frame: baseline to 24 hours
Population: Study was prematurely terminated. No data were collected for this assessment
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
Time frame: baseline to 24 hours post block
Population: Study was prematurely terminated. No data were collected for this assessment
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.
Time frame: baseline to discharge from hospital (expected 3 days)
Population: Study was prematurely terminated. No data were collected for this assessment
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
Time frame: baseline to 24 hours post block
Population: Study was prematurely terminated. No data were collected for this assessment
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
Time frame: baseline to discharge (approximately 72 hours)
Population: Study was prematurely terminated. No data were collected for this assessment