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This prospective randomized clinical trial evaluates the duration of sensory blockade in patients undergoing shoulder surgery receiving interscalene brachial plexus blocks with either liposomal bupivacaine alone or liposomal bupivacaine combined with dexamethasone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposomal Bupivacaine Alone | Active Comparator | Participants receive an interscalene brachial plexus nerve block consisting of 10 mL liposomal bupivacaine (133 mg) combined with 20 mL of 0.5% bupivacaine. This regimen represents standard of care for prolonged regional analgesia in shoulder surgery. |
|
| Liposomal Bupivacaine + Dexamethasone | Experimental | Participants receive an interscalene brachial plexus nerve block consisting of 10 mL liposomal bupivacaine (133 mg) combined with 20 mL of 0.5% bupivacaine and 6 mg preservative-free dexamethasone. This arm evaluates whether the addition of dexamethasone prolongs sensory blockade duration compared to liposomal bupivacaine alone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal Bupivacaine with Bupivacaine | Drug | Administration of an interscalene brachial plexus nerve block using 10 mL liposomal bupivacaine (133 mg) and 20 mL of 0.5% bupivacaine for postoperative analgesia following shoulder surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| time until resolution of sensory block | Patients will be called daily until resolution of their sensory block | 0-10 days |
| Measure | Description | Time Frame |
|---|---|---|
| duration of motor blockade | 2, 12, 24, 36, 48, 72, and 96 hours postoperatively | |
| pain scores (scale of 0-10) | Numeric Pain Rating Scale (NPRS): A score of 0 means "no pain," and 10 means "the worst pain imaginable |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emily Hall | Duke University | Principal Investigator |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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Provider given care is not preparing study drug
| Dexamethasone | Drug | 6 mg preservative-free dexamethasone |
|
| 2, 12, 24, 36, 48, 72, and 96 hours postoperatively |
| opioid consumption (in oral morphine equivalents) | 2, 12, 24, 36, 48, 72, and 96 hours postoperatively |
| known side effects of interscalene blocks | 2, 12, 24, 36, 48, 72, and 96 hours postoperatively |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |