- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02151487
A Comparison of Ropivacaine Alone Versus Combination of Dexamethasone and Clonidine for Block
A Comparison of Ropivacaine Alone Versus Ropivacaine With Dexamethasone or Clonidine Versus a Combination of Ropivacaine, Dexamethasone, and Clonidine for Supraclavicular Brachial Plexus Block Using Ultrasound:A Prospective, Observer-blinded, Randomized Study
Study Overview
Status
Conditions
Detailed Description
Subjects undergoing orthopedic surgery of upper extremities were randomized to be one of the three groups to receive supraclavicular nerve block with group 1: ropivacaine alone; group 2: ropivacaine and dexamethasone; group 3: ropivacaine and clonidine or group 4: ropivacaine and dexamethasone and clonidine combination.
Subjects were identified at the day surgery unit at Parkland hospital before the procedure and approached by their physician, the primary investigator, or research personnel for the consent for the study. If the subjects chooses and consents fully to participate, he or she was randomly assigned to receive one of the previously described local anesthetics for supraclavicular nerve block.
The following clinical outcomes were assessed for up to 24 hr: Duration of the block, onset of the block, postoperative pain scores, nausea, vomiting, and complications of peripheral nerve block. Pain was evaluated by using a linear 10-cm visual analog scale (VAS; 0=no pain, 10= worst imaginable pain) immediately before the block, 5, 10, 15 minutes and postoperatively on the arrival of Post Anesthesia Care Unit (PACU) within 15 minutes, discharge from the Day surgery Unit, and 24 hr. later at home via phone call visit.
Sensory and motor block in the related nerve dermatomes were assessed. Patient was instructed to document at what time did hand motion (finger movement) return and what time normal sensation return. Specific time for both events was sked to patient at phone call visit 24 hr later. Overall patient satisfaction was evaluated at the discharge from the day surgery and 24 hr after the block via phone visit.
At any point in which the patient is not experiencing pain relief after having received the injection, they were removed from the study and other anesthetic techniques will be applied to resolve their pain along with pharmacological management of their pain. Rescue antiemetic, which is standard of care, will be given to any patient who complains of nausea or vomiting.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Texas
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Dallas, Texas, United States, 750390
- Parkland Health Hospital System
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Men and women 18-80 years old
- Undergoing upper extremity surgery
- Receiving Supraclavicular block
- Receiving ropivacaine, ropivacaine adjuvants (dexamethasone, clonidine) for the supraclavicular nerve block.
- Able to give Informed consent
Exclusion Criteria:
- Age less than 18 and greater than 80 years
- Inability to understand the study procedures
- Significant respiratory dysfunction
- Preexisting neurologic deficits
- Allergy to local anesthetics
- A bleeding diathesis or on anticoagulants
- Systemic glucocorticoid use
- Refuse to participate in the study
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Ropivacaine
Ropivacaine 0.5% 25 ml alone for supraclavicular block
|
Ropivacaine alone
Other Names:
|
Ropivacaine and dexamethasone
25 ml 0.5% ropivacaine + 4 mg dexamethasone
|
Ropivacaine combination with dexamethasone
Other Names:
|
Ropivacaine and clonidine
25 ml 0.5% ropivacaine + 100 mcg clonidine
|
Ropivacaine combination with clonidine
Other Names:
|
Ropivacaine, dexamethasone and clonidine
25 ml 0.5% ropivacaine + 4 mg dexamethasone + 100 mcg clonidine
|
Ropivacaine combination with dexamethasone and clonidine
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of the Sensorial Supraclavicular Block
Time Frame: within 24-hr after surgery
|
Duration of sensorial block defined as the time interval between subject admitted to the Post-Anesthesia Care Unit and the time the first pain medication taken at home
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within 24-hr after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative Analgesia
Time Frame: within 15 minutes at postanesthesia care unit (PACU) arrival
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Post-operative Visual Analog Pain (VAS) scores on the scale of 10 (0=no pain and 10=worse imaginary pain).
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within 15 minutes at postanesthesia care unit (PACU) arrival
|
Collaborators and Investigators
Investigators
- Principal Investigator: Dawood Nasir, MD, University of Texas Southwestern Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anesthetics
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Protease Inhibitors
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Anesthetics, Local
- Sympatholytics
- Dexamethasone
- Dexamethasone acetate
- BB 1101
- Ropivacaine
- Clonidine
Other Study ID Numbers
- 102013-068
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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