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Pre-operative perineural injection of dexamethasone mixed with local anesthetic in peripheral nerve blockade for orthopedic surgery has been shown to prolong the length of analgesia, improve visual analog pain scores, decrease post-operative opioid use, and decrease post-operative nausea. No study has been published to determine if this effect is a result of systemic absorption of dexamethasone or is a local effect of the drug on neuronal activity at the injection site. This study is a prospective, randomized, double-blind, controlled study to compare pain block with (1) ropivacaine and saline plus intravenous saline vs (2) ropivacaine and dexamethasone plus intravenous saline vs (3) ropivacaine and saline plus intravenous dexamethasone. Patients will be recruited sequentially and assigned to the three groups at random in equal ratios. The hypothesis is that dexamethasone injected perineurally in combination with ropivacaine for interscalene brachial plexus block will yield longer duration of sensory blockade as compared to ropivacaine alone without intravenous or perineural dexamethasone and as compared to ropivacaine and intravenous dexamethasone. This result will suggest that the effect of dexamethasone is a result of direct neuronal activity at the injection site versus systemic absorption.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone block | Experimental | Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline |
|
| Dexamethasone IV | Active Comparator | Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml |
|
| Placebo | Placebo Comparator | Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Drug | 25 ml ropivacaine 0.5% |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Sensory Blockade | Duration from time of block until complete resolution of sensory blockade in the shoulder is recorded in minutes by patient report. | Within 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Post Operative Opioid Dose at 24 Hours | approximately 24 hours after surgery | |
| Time Until First Dose of Analgesic | Approximately 10 hours after surgery | |
| Patient Satisfaction With Pain Control |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Rosenfeld, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Phoenix | Arizona | 85259 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26899862 | Result | Rosenfeld DM, Ivancic MG, Hattrup SJ, Renfree KJ, Watkins AR, Hentz JG, Gorlin AW, Spiro JA, Trentman TL. Perineural versus intravenous dexamethasone as adjuncts to local anaesthetic brachial plexus block for shoulder surgery. Anaesthesia. 2016 Apr;71(4):380-8. doi: 10.1111/anae.13409. Epub 2016 Feb 22. |
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238 patients were screened; of these 41 were excluded because they did not meet inclusion criteria, and 67 were excluded because they declined to be in the study.
Participants were recruited at Mayo Clinic in Arizona from June 2012 to September 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexamethasone Block | Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline |
| FG001 | Dexamethasone IV | Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml |
| FG002 | Placebo | Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexamethasone Block | Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline |
| BG001 | Dexamethasone IV | Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Baseline measures were provided for participants who completed the study. |
| 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 Sensory Blockade | Duration from time of block until complete resolution of sensory blockade in the shoulder is recorded in minutes by patient report. | Patients will be included in the primary analysis on the basis of intention to treat. | Posted | Mean | Standard Deviation | hours | Within 48 hours |
|
One week
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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 | Dexamethasone Block | Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospital admission for fall | Injury, poisoning and procedural complications | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
Although it was designed to have 80% power at 120 patients, double this number would be required to detect very small differences (<10%) in the systemic and perineural groups.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David M. Rosenfeld | Mayo Clinic | 480-301-7586 | Rosenfeld.David@mayo.edu |
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| ID | Term |
|---|---|
| D000070599 | Shoulder Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D003907 | Dexamethasone |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Dexamethasone | Drug | 8 mg dexamethasone (perineural) |
|
| Dexamethasone | Drug | 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml (intravenous) |
|
| Normal saline | Drug | 5 ml normal saline (intravenous) |
|
| Normal saline | Drug | 0.8 ml normal saline (perineural) |
|
Pain was rated on a visual analogue scale with 0 = no pain, 3=mild pain, 5=moderate pain, 7=moderate to severe pain, and 10=severe pain. |
| 24 hours, 48 hours, 1 week |
| Adverse Event |
|
| BG002 | Placebo | Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline |
| BG003 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Placebo | Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline |
|
|
|
| Secondary | Post Operative Opioid Dose at 24 Hours | The number of participants analyzed is different from the number of participants in each arm who completed the trial because data were not available for 1 participant in the Dexamethasone IV group and 1 participant in the placebo group. | Posted | Mean | Standard Deviation | mg morphine equivalents | approximately 24 hours after surgery |
|
|
|
|
| Secondary | Time Until First Dose of Analgesic | The number of participants analyzed is different from the number of participants in each arm who completed the trial because data were not available for 1 participant in the Dexamethasone IV group and 1 participant in the placebo group. | Posted | Mean | Standard Deviation | hours | Approximately 10 hours after surgery |
|
|
|
|
| Secondary | Patient Satisfaction With Pain Control | Pain was rated on a visual analogue scale with 0 = no pain, 3=mild pain, 5=moderate pain, 7=moderate to severe pain, and 10=severe pain. | Patients analyzed for each category varied see explanations per row (time point): (n=dexamethasone block, dexamethasone IV, placebo). | Posted | Mean | Standard Deviation | units on a scale | 24 hours, 48 hours, 1 week |
|
|
|
|
| 0 |
| 42 |
| 8 |
| 42 |
| EG001 | Dexamethasone IV | Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml | 3 | 37 | 2 | 37 |
| EG002 | Placebo | Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline | 1 | 41 | 5 | 41 |
| Hospital admission for bowel infection | Infections and infestations | Systematic Assessment |
|
| Motor vehicle accident with fractured sternum | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Syncope | Blood and lymphatic system disorders | Systematic Assessment |
|
| 10 lb fluid weight within 24 hours | General disorders | Systematic Assessment | Resolved without issue |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| ER for nausea and vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Fainting | Blood and lymphatic system disorders | Systematic Assessment |
|
| Frequent urination | Renal and urinary disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Hoarse | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Muscle soreness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Wrist, hand, and finger pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Cranial nerve XII motor tongue | Nervous system disorders | Systematic Assessment |
|
| Difficulty breathing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D000588 |
| Amines |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
|
| 1 week (n=42, 36, 41) |
|
| Kruskal-Wallis |
| 0.13 |
| No |
| Superiority or Other |
| Comparison between the 3 groups for pain scores at 1 week. | Kruskal-Wallis | 0.25 | No | Superiority or Other |