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The purpose of this study is to determine whether a small dose of Dexmedetomidine, when given either intravenously or as part of the interscalene nerve block solution, prolongs pain relief following shoulder surgery compared to local anesthetic solution alone.
Unilateral shoulder surgical procedures, including acromioplasty, rotator cuff repair and Bankart procedure generally allow the patient to go home the same day. However, post-surgical pain is often severe and it is common to encounter a delay in discharge from the hospital due to difficulty in pain control.
Single shot interscalene block is used in ambulatory shoulder surgery for its advantages that included a significant reduction in acute pain and analgesic requirements, prolonged time to first analgesic request, decreased incidence of nausea, as well as earlier hospital discharge. Previous studies have attempted to prolong the duration of the analgesia of interscalene block by administering additional drugs to the local anesthetics but these studies have had varying degrees of success. Dexmedetomidine has recently been considered as a potentially useful drug in prolonging nerve block analgesia. Various modes of administration of Dexmedetomidine have demonstrated a consistent effect on the duration of analgesia. So far, the systemic infusion of Dex has been shown to prolong both neuraxial and peripheral nerve blocks. When combined with local anesthetics in intravenous regional anesthesia 9IVRA), Dex enhanced the duration of analgesia. Furthermore, data from animal studies strongly support the use of Dex as a safe potent adjunct to local anesthetics capable of prolonging the duration of analgesia of peripheral nerve blocks.
The use of Dexmedetomidine as an adjunct in interscalene block has not been studied yet. This trial will study the effects of adding Dexmedetomidine as an adjunct to local anesthetics in interscalene brachial plexus block.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropivacaine,Normal Saline,Saline Bolus | Placebo Comparator | Ropivacaine 15 mL 0.5% Normal Saline mL 0.9% Saline Bolus |
|
| Ropivacaine,Dexmedetomidine,Saline Bolus | Experimental | Ropivacaine15 mL 0.5% Dexmedetomidine0.5 u/kg Saline Bolus |
|
| Ropivacaine,Saline,Dexmedetomidine | Active Comparator | Ropivacaine 15 mL 0.5% Normal Saline 1 mL 0.9% Dexmedetomidine single IV bolus 0.5 u/kg over 30 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | 0.5 u/kg Dexmedetomidine diluted in saline to 1 mL (single interscalene injection) Dexmedetomidine 0.5 u/kg as a single IV bolus over 30 minutes following GA induction |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of interscalene nerve block. | Duration of time is from the end of local anesthetic injection (interscalene block) to the onset of pain at the surgical site. | |
| Opioid consumption | Cumulative opioid consumption at 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Consumption | The total amount of opioid use starting from during surgery to 14 days following surgery. Opioid side effects, patient satisfaction with pain control and the time to discharge from hospital will all be assessed Any evidence of nerve block complications at 3 months, post-block administration , will also be assessed. | Total use of opioids from the period of intra-operative to 2 weeks post-operative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard M. Brull, MD, FRCPC | University of Toronto, Women's College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's College Hospital | Toronto | Ontario | M5S 1B2 | Canada |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D020069 | Shoulder Pain |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D000077212 | Ropivacaine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Ropivacaine | Drug | 15 ml 0.5% |
|
|
| Normal Saline | Drug | 1 mL 0.9% |
|
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000813 |
| Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |