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The purpose of this study is to test the efficacy and safety of dexmedetomidine added to ropivacaine in patients undergoing shoulder surgery.
Peripheral nerve blocks are used throughout the world in lieu of general anesthesia and, more commonly, to provide analgesia and opioid sparing in the postoperative course. Long acting local anesthetics, such as ropivacaine, can provide analgesia for 11.5 ± 5 hours. This leads to many patients reporting their first pain in the evening and nighttime hours when access to healthcare providers and support is most limited. A number of additives to local anesthetics have been studied in humans with limited success. Recent work by a group in Michigan found a dose dependent increase in the duration of analgesia to a thermal stimulus when dexmedetomidine was added to ropivacaine for sciatic nerve blocks in rat.
The goal of the study is to investigate the safety and efficacy of dexmedetomidine added to ropivacaine for interscalene brachial plexus nerve block for shoulder surgery in humans. Provided the initial safety can be established, the trial will continue to evaluate secondary goals including the duration of analgesia, onset of sensory and motor blockade, and opioid-induced side effects. Tertiary outcomes will include subject satisfaction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ropivacaine + dexmedetomidine | Experimental | This group represents the standard of care drug (ropivacaine) plus the new additive to be studied (dexmedetomidine) |
|
| ropivacaine + saline | Active Comparator | This group represents the current standard of care in peripheral nerve blockade |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexmedetomidine | Drug | ropivacaine 100 mg + 150 mcg dexmedetomidine, single shot perineural application |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of dexmedetomidine in perineural application | The time until the patient describes the blockade as completely gone will be analysed and compared between the groups. | 24 hrs |
| Safety of dexmedetomidine in perineural application | Any serious and/or unexpected adverse (AE) events will be assessed on an individual basis by the Principal Investigator and the DSMB. After the first twenty subjects (10 controls and 10 receiving study agent) have completed the study, the data will be reviewed. Provided the DSMB determines the initial safety is established, enrollment will proceed until a total of 62 subjects (31 subjects/group) have been accrued. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Analgesia | Analgesia will be assessed based on postoperative pain scores | first 24-48 hrs |
| Onset of sensory blockade | The subject's sensory function will be measured every 2 minutes for the first 20 minutes, until the loss of sensory function in the dermal distribution of the shoulder. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Gerner, MD | Paracelsus Medical University Salzburg, Department of Anesthesiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paracelsus Medical University, Department of Anesthesiology, Perioperative and Intensive Care Medicine | Salzburg | 5020 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20814283 | Background | Brummett CM, Amodeo FS, Janda AM, Padda AK, Lydic R. Perineural dexmedetomidine provides an increased duration of analgesia to a thermal stimulus when compared with a systemic control in a rat sciatic nerve block. Reg Anesth Pain Med. 2010 Sep-Oct;35(5):427-31. doi: 10.1097/AAP.0b013e3181ef4cf0. | |
| 21666435 | Background |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| saline | Drug | ropivacaine + saline placebo, single shot perineural application |
|
| every 3 minutes for the first 21 minutes |
| Duration of motor blockade | The time to return of motor strength will be recorded in the subject's postoperative course. | first 24-48 hrs |
| Opioid-induced side effects | Opioid-induced side effects will be recorded in the subject's postoperative course. | first 24-48 hrs |
| Brummett CM, Hong EK, Janda AM, Amodeo FS, Lydic R. Perineural dexmedetomidine added to ropivacaine for sciatic nerve block in rats prolongs the duration of analgesia by blocking the hyperpolarization-activated cation current. Anesthesiology. 2011 Oct;115(4):836-43. doi: 10.1097/ALN.0b013e318221fcc9. |
| 19858875 | Background | Brummett CM, Padda AK, Amodeo FS, Welch KB, Lydic R. Perineural dexmedetomidine added to ropivacaine causes a dose-dependent increase in the duration of thermal antinociception in sciatic nerve block in rat. Anesthesiology. 2009 Nov;111(5):1111-9. doi: 10.1097/ALN.0b013e3181bbcc26. |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |