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Previous studies have confirmed that IV dexamethasone prolongs brachial plexus blocks. However, these studies only used fixed doses of IV dexamethasone at relatively high doses, which could potentially lead to increased glucose levels, delayed wound healing, and unintended side effects. There remains a paucity of research on the effective dose range of IV dexamethasone for the prolongation of supraclavicular blocks. The optimal dosage of IV dexamethasone for prolongation of analgesia vs. motor block prolongation from supraclavicular blocks in shoulder surgery has yet to be delineated.
Numerous studies have confirmed that perineural dexamethasone prolongs bupivacaine and ropivacaine brachial plexus blocks by approximately 10 hours (from approx. 12 to 22 hours) without clinical evidence of toxicity. However, perineural toxicity in an animal model has raised concern about its use as a peripheral nerve block adjuvant. Moreover, recent studies suggest that high dose IV dexamethasone (810mg) prolongs analgesia to a similar degree as perineural dexamethasone for interscalene, supraclavicular and sciatic nerve blocks performed with ropivacaine and bupivacaine. However these studies only utilized fixed, high level doses of IV dexamethasone. Moreover, there remains a concern that high dose IV dexamethasone may lead to postoperative hyperglycemia and could possibly increase the risk of postoperative wound infection. Open surgery under general anesthesia has been shown to increase blood glucose levels with a peak at approximately 2 hours post-induction and results have been conflicting regarding whether or not IV dexamethasone causes greater increase. To the investigators' knowledge, it is not yet known if arthroscopic surgery under regional anesthesia triggers a similar increase in blood glucose levels and if this is impacted by administration of IV dexamethasone. The investigators aim to identify the duration of supraclavicular block prolongation that can be expected over a range of doses of IV dexamethasone. The investigators also seek to identify what association, if any, is noted between IV dexamethasone and changes in blood glucose levels after shoulder surgery with regional anesthesia and sedation. Finally, the investigators will collect data on side effects and postoperative complications, if any, in patients receiving a range of doses of IV dexamethasone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0mg IV Dexamethasone | Placebo Comparator | 0mg IV Dexamethasone |
|
| 4mg IV Dexamethasone | Experimental | 4mg IV Dexamethasone |
|
| 6mg IV Dexamethasone | Experimental | 6mg IV Dexamethasone |
|
| 8mg IV Dexamethasone | Experimental | 8mg IV Dexamethasone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV Saline | Drug |
| ||
| IV Dexamethasone 4mg |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Analgesia From a Supraclavicular Block Performed for Shoulder Arthroscopy | Defined as time from block placement until "pain relief from the block completely wears off" in the operative shoulder. | Day of Surgery until Post-Operative Day 3 (if the block persists) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Motor Block From the Supraclavicular Block | Defined as the time from block placement to restoration of normal strength at both the wrist and elbow. | Day of Surgery until Post-Operative Day 3 (if the block persists) |
| Blood Glucose Levels |
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Inclusion Criteria:
- Patients undergoing shoulder arthroscopy under regional anesthesia
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Meghan Kirksey, MD, PhD | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 0mg IV Dexamethasone | 0mg IV Dexamethasone IV Saline |
| FG001 | 4mg IV Dexamethasone | 4mg IV Dexamethasone IV Dexamethasone 4mg |
| FG002 | 6mg IV Dexamethasone | 6mg IV Dexamethasone IV Dexamethasone 6mg |
| FG003 | 8mg IV Dexamethasone | 8mg IV Dexamethasone IV Dexamethasone 8mg |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 0mg IV Dexamethasone | 0mg IV Dexamethasone |
| BG001 | 4mg IV Dexamethasone | 4mg IV Dexamethasone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Duration of Analgesia From a Supraclavicular Block Performed for Shoulder Arthroscopy | Defined as time from block placement until "pain relief from the block completely wears off" in the operative shoulder. | Posted | Median | 95% Confidence Interval | Hours | Day of Surgery until Post-Operative Day 3 (if the block persists) |
|
These protocol deviations were between 4/7/17-10/9/2017. Patients were followed for 3 days after surgery.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 0mg IV Dexamethasone | 0 mg IV Dexamethasone Adverse Event | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Protocol Deviation | Surgical and medical procedures | Systematic Assessment | Medication dosage changes, change of procedure during surgery. These were reported as protocol deviations |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Meghan Kirksey, MD, PhD | Hospital for Special Surgery | 212-606-1206 | Kirkseym@hss.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 29, 2016 | May 7, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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|
| IV Dexamethasone 6mg | Drug |
|
| IV Dexamethasone 8mg | Drug |
|
Fingerstick blood glucose test to be administered before and 1-hour and 2-hours after IV dexamethasone administration.
| Day of Surgery - before and 1-hour and 2-hours after IV Dexamethasone administration |
| Occurrence of Postoperative Neuropraxia | Documentation of any of these occurrences will be obtained from the surgeons and/or medical charts after the postoperative follow up visit. | Post-Operative Day 21 |
| Occurrence of Postoperative Wound Infection | Documentation of any of these occurrences will be obtained from the surgeons and/or medical charts after the postoperative follow up visit. | Post-Operative Day 21 |
| Average Daily Pain Scores at Rest and With Movement | Using the Numeric Rating Scale (NRS) Pain obtained by patient interview. Lower numbers represent less pain and better outcomes. The scale range is from 0 (no pain) to 10 (worst pain possible). | Day of Surgery until Post-Operative Day 3 (if the block persists) |
| Worst Daily Pain Scores at Rest and With Movement | Using the numeric pain rating scale (NRS), will be obtained by patient interview. Lower numbers represent less pain and better outcomes. The scale range is from 0 (no pain) to 10 (worst pain possible). | Day of Surgery until Post-Operative Day 3 (if the block persists) |
| Patient Satisfaction With Postoperative Analgesia | Patient satisfaction with postoperative analgesia will be obtained by patient interview. Lower numbers represent worse outcomes. The scale range is from 0 (worst) to 10 (best). | Post-Operative Day 2 or Post-Operative Day 3 (if the block persists) |
| Cumulative Daily Opioid Usage | Dosages (reported in Morphine equivalent units) of opioid medication obtained by medical records and/or by patient interview. | Recovery Room until Post-Operative Day 3 (if block persists) |
| Lost to Follow-up |
|
| BG002 |
| 6mg IV Dexamethasone |
6mg IV Dexamethasone |
| BG003 | 8mg IV Dexamethasone | 8mg IV Dexamethasone |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | full range | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
6mg IV Dexamethasone
| OG003 | 8mg IV Dexamethasone | 8mg IV Dexamethasone |
|
|
| Secondary | Duration of Motor Block From the Supraclavicular Block | Defined as the time from block placement to restoration of normal strength at both the wrist and elbow. | shoulder arthroscopy | Posted | Median | 95% Confidence Interval | Hours | Day of Surgery until Post-Operative Day 3 (if the block persists) |
|
|
|
| Secondary | Blood Glucose Levels | Fingerstick blood glucose test to be administered before and 1-hour and 2-hours after IV dexamethasone administration. | Prior to IV Dexamethasone, 1-hour and 2-hours after IV Dexamethasone administration | Posted | Median | Standard Deviation | mg/dL | Day of Surgery - before and 1-hour and 2-hours after IV Dexamethasone administration |
|
|
|
| Secondary | Occurrence of Postoperative Neuropraxia | Documentation of any of these occurrences will be obtained from the surgeons and/or medical charts after the postoperative follow up visit. | Posted | Count of Participants | Participants | Post-Operative Day 21 |
|
|
|
| Secondary | Occurrence of Postoperative Wound Infection | Documentation of any of these occurrences will be obtained from the surgeons and/or medical charts after the postoperative follow up visit. | Posted | Count of Participants | Participants | Post-Operative Day 21 |
|
|
|
| Secondary | Average Daily Pain Scores at Rest and With Movement | Using the Numeric Rating Scale (NRS) Pain obtained by patient interview. Lower numbers represent less pain and better outcomes. The scale range is from 0 (no pain) to 10 (worst pain possible). | Average daily pain scores Pre-Op to POD3 at rest and with movement. | Posted | Mean | Standard Deviation | score on a scale | Day of Surgery until Post-Operative Day 3 (if the block persists) |
|
|
|
| Secondary | Worst Daily Pain Scores at Rest and With Movement | Using the numeric pain rating scale (NRS), will be obtained by patient interview. Lower numbers represent less pain and better outcomes. The scale range is from 0 (no pain) to 10 (worst pain possible). | Worst Daily Pain Scores at rest and with movement from Pre-Op to POD3 | Posted | Mean | Standard Deviation | score on a scale | Day of Surgery until Post-Operative Day 3 (if the block persists) |
|
|
|
| Secondary | Patient Satisfaction With Postoperative Analgesia | Patient satisfaction with postoperative analgesia will be obtained by patient interview. Lower numbers represent worse outcomes. The scale range is from 0 (worst) to 10 (best). | Patient Satisfaction with Post-Op Analgesia | Posted | Mean | Standard Deviation | score on a scale | Post-Operative Day 2 or Post-Operative Day 3 (if the block persists) |
|
|
|
| Secondary | Cumulative Daily Opioid Usage | Dosages (reported in Morphine equivalent units) of opioid medication obtained by medical records and/or by patient interview. | Cumulative Daily Opioid Usage | Posted | Mean | Standard Deviation | oral morphine equivalent units (mg) | Recovery Room until Post-Operative Day 3 (if block persists) |
|
|
|
| 35 |
| 0 |
| 35 |
| 4 |
| 35 |
| EG001 | 4mg IV Dexamethasone | 4 mg IV Dexamethasone Adverse Event | 0 | 34 | 0 | 34 | 2 | 34 |
| EG002 | 6mg IV Dexamethasone | 6 mg IV Dexamethasone Adverse Event | 0 | 33 | 0 | 33 | 6 | 33 |
| EG003 | 8mg IV Dexamethasone | 8 mg IV Dexamethasone Adverse Event | 0 | 35 | 0 | 35 | 3 | 35 |
|
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| D017670 |
| Sodium Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| 1 hour after IV Dexamethasone |
|
| 2 hours after IV Dexamethasone |
|
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| POD0 Average Pain Score at rest |
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| POD1 Average Pain Score at rest |
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| POD2 Average Pain Score at rest |
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| POD3 Average Pain Score at rest |
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| Pre-Op Average Pain Score with Movement |
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| POD0 Average Pain Score with Movement |
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| POD1 Average Pain Score with Movement |
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| POD2 Average Pain Score with Movement |
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| POD3 Average Pain Score with Movement |
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| POD0 Worst Pain Score at rest |
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| POD1 Worst Pain Score at rest |
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| POD2 Worst Pain Score at rest |
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| POD3 Worst Pain Score at rest |
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| Pre-Op Worst Pain Score with Movement |
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| POD0 Worst Pain Score with Movement |
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| POD1 Worst Pain Score with Movement |
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| POD2 Worst Pain Score with Movement |
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| POD3 Worst Pain Score with Movement |
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| POD2 (24-48hrs) |
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