A Comparison of Ropivacaine Alone Versus Combination of Dexamethasone and Clonidine for Block

Study Overview
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Brief Summary
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The aim of this randomized, observer-blinded study is to evaluate the postoperative analgesic efficacy of adding dexamethasone and clonidine to ropivacaine in supraclavicular nerve block. The investigators hypothesized that addition of dexamethasone and clonidine to ropivacaine would prolong the duration of analgesia in supraclavicular nerve block compared with ropivacaine alone.

Detailed Description
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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.

Official Title
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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

Conditions
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Upper Extremity Surgery

Intervention / Treatment
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* Drug: Ropivacaine
* Drug: Ropivacaine and dexamethasone
* Drug: Ropivacaine and clonidine
* Drug: Ropivacaine, dexamethasone and clonidine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ropivacaine<br>Ropivacaine 0.5% 25 ml alone for supraclavicular block | Drug: Ropivacaine<br>* Ropivacaine alone<br>* Other names: Noropin;|
| Ropivacaine and dexamethasone<br>25 ml 0.5% ropivacaine + 4 mg dexamethasone | Drug: Ropivacaine and dexamethasone<br>* Ropivacaine combination with dexamethasone<br>* Other names: Noropin and adjuvant;|
| Ropivacaine and clonidine<br>25 ml 0.5% ropivacaine + 100 mcg clonidine | Drug: Ropivacaine and clonidine<br>* Ropivacaine combination with clonidine<br>* Other names: Noropin and adjuvants;|
| Ropivacaine, dexamethasone and clonidine<br>25 ml 0.5% ropivacaine + 4 mg dexamethasone + 100 mcg clonidine | Drug: Ropivacaine, dexamethasone and clonidine<br>* Ropivacaine combination with dexamethasone and clonidine<br>* Other names: Noropin and adjuvants;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of the Sensorial Supraclavicular Block | 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 | within 24-hr after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Analgesia | Post-operative Visual Analog Pain (VAS) scores on the scale of 10 (0=no pain and 10=worse imaginary pain). | within 15 minutes at postanesthesia care unit (PACU) arrival | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Supraclavicular block, Ropivacaine, Dexamethasone, Clonidine, Postoperative analgesia