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Patients scheduled to have foot and ankle surgery will typically receive a single shot sciatic nerve block to serve as the primary anesthetic and as part of a multi-modal post-operative analgesic plan. The investigators are investigating the use of perineural dexamethasone together with local anesthetics can improve the quality of recovery for patients receiving sciatic nerve blocks for foot and ankle surgery.
Patients scheduled to have foot and ankle surgery will typically receive a single shot sciatic nerve block to serve as the primary anesthetic and as part of a multi-modal post-operative analgesic plan. Perineural dexamethasone has been investigated as an adjuvant for brachial plexus nerve blocks but its effect on sciatic nerve block outcomes has yet to be determined. More importantly, it is not known whether the beneficial effect of perineural dexamethasone on analgesia duration leads to a better quality of surgical recovery. We hypothesized that perineural dexamethasone leads to a better quality of postsurgical recovery than intravenous dexamethasone or saline control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perineural Dexamethasone | Active Comparator | Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine and perineural dexamethasone 8mg/2mL, and 50mL IV normal saline infusion |
|
| Intravenous Dexamethasone | Active Comparator | Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline and IV dexamethsone 8mg in 50mL infusion |
|
| No Perioperative Steroids | Placebo Comparator | Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline and 50mL infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | IV dexamethsone 8mg in 50mL (diluted in NS) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Recovery | QoR-40 questionnaire instrument consists of 40 questions that examine 5 domains of patient recovery using a 5 point Likert scale: none of the time, some of the time, usually, most of the time and all of the time. The five domains include physical comfort, pain, physical independence, psychological support and emotional state. Global QoR-40 scores range from minimum of 40 to a maximum of 200. The scores are added together to compute a total score. A low score of 40 represents very poor quality of recovery while a high score, i.e. 200 represents outstanding quality of recovery. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Consumption | Postoperative opioid consumption was converted to equivalent dose of oral morphine at two weeks following surgery. | 2 weeks |
| Pain Scores | Patients were asked to rate their pain score during activity on a 11-point scale (0 = no pain to 10 = excruciating pain). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rohit Rahangdale, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University, Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Perineural Dexamethasone | Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine and perineural dexamethasone 8mg/2mL ,and 50mL IV normal saline infusion |
| FG001 | Intravenous Dexamethasone | Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and IV dexamethsone 8mg in 50mL infusion |
| FG002 | No Perioperative Steroids | Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and 50mL saline infusion |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Perineural Dexamethasone | Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine and perineural dexamethasone 8mg/2mL ,and 50mL IV normal saline infusion |
| BG001 | Intravenous Dexamethasone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Quality of Recovery | QoR-40 questionnaire instrument consists of 40 questions that examine 5 domains of patient recovery using a 5 point Likert scale: none of the time, some of the time, usually, most of the time and all of the time. The five domains include physical comfort, pain, physical independence, psychological support and emotional state. Global QoR-40 scores range from minimum of 40 to a maximum of 200. The scores are added together to compute a total score. A low score of 40 represents very poor quality of recovery while a high score, i.e. 200 represents outstanding quality of recovery. | Posted | Median | Inter-Quartile Range | units on a scale | 2 weeks |
|
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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 | Perineural Dexamethasone | Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine and perineural dexamethasone 8mg/2mL ,and 50mL IV normal saline infusion |
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We enrolled a very specific surgical patient population and all surgical procedures required a saphenous nerve block and the pain in the saphenous nerve distribution could have affected some of our results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rohit Rahangdale MD | Northwestern University, Feinberg School of Medicine | 312-695-3045 | ryrahangdale@hotmail.com |
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| ID | Term |
|---|---|
| D064386 | Ankle Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D016512 | Ankle Injuries |
| D007869 | Leg Injuries |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Dexamethasone | Drug | 8mg/2mL |
|
|
| Saline | Drug | 2mL |
|
|
| 2 weeks |
Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and IV dexamethsone 8mg in 50mL infusion
| BG002 | No Perioperative Steroids | Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and 50mL saline infusion |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Intravenous Dexamethasone |
Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and IV dexamethsone 8mg in 50mL infusion |
| OG002 | No Perioperative Steroids | Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and 50mL saline infusion |
|
|
| Secondary | Opioid Consumption | Postoperative opioid consumption was converted to equivalent dose of oral morphine at two weeks following surgery. | Posted | Median | Inter-Quartile Range | mg/day | 2 weeks |
|
|
|
| Secondary | Pain Scores | Patients were asked to rate their pain score during activity on a 11-point scale (0 = no pain to 10 = excruciating pain). | Posted | Median | Inter-Quartile Range | units on a scale | 2 weeks |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | Intravenous Dexamethasone | Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and IV dexamethsone 8mg in 50mL infusion | 0 | 24 | 0 | 24 |
| EG002 | No Perioperative Steroids | Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and 50mL saline infusion | 0 | 27 | 0 | 27 |
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| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |