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This study will investigate the ability of systemic dexamethasone to prolong the sensory block duration for lumbar plexus nerve blockade.
The purpose of this randomized, double-blinded, placebo-controlled trial is to examine the equivalency of two different doses of dexamethasone when given intravenously as an adjuvant medication for postoperative pain management. Specifically, this study will investigate the prolongation of time to recovery of sensation following a lumbar plexus block in patients undergoing total hip arthroplasties. The investigators hypothesize that dexamethasone will prolong the sensory block time when compared to placebo and that similar results will be obtained in the 4 mg arm when compared to the 8 mg arm. The primary end point will be time to sensory recovery in the femoral nerve cutaneous distribution (part of the lumbar plexus) as determined by pin-prick sensation assessment. Secondary endpoints will include, but are not be limited to: time to first opioid administration, total opioid consumption over 30 hours, and rest and incident verbal numerical pain scores at 6,12,18,24 and 30 hours post block placement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4 mg dexamethasone group | Experimental | Following lumbar plexus nerve block administration using bupivacaine and epinephrine, 4 mg of systemic dexamethasone will be administered to this group intravenously. The volume given intravenously will be identical for all groups. |
|
| 8 mg dexamethasone group | Experimental | Following peripheral nerve block using bupivacaine and epinephrine administration, 8 mg of systemic dexamethasone will be administered to this group intravenously. The volume given intravenously will be identical for all groups. |
|
| Control Group | Placebo Comparator | Normal saline will be used as a placebo control group given at the same time and in the same manner as the experimental groups following peripheral nerve block administration. The volume given intravenously will be identical for all groups. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | A lumbar plexus nerve block will be performed for patients undergoing hip arthroplasty. A total of 25cc's of 0.25% bupivacaine with 1:400,000 epinephrine will be administered for postoperative analgesia. Surgical anesthesia will be provided either by an intrathecal spinal block or general anesthesia. Successful blockade will be assumed if the patient has a decrease or loss of pinprick sensation in the femoral nerve distribution, which innervates the anterior thigh. If no evidence of blockade is present, testing will occur again at 30 minutes post block. Testing will be performed with a 25 gauge Whitacre needle and once present the area of testing will be marked with a surgical marking pen so that repeat sensory testing can be undertaken at that same site over the course of the study. The subjects will then receive dexamethasone (4 or 8 mg) or placebo (saline) based on arm placement. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Sensory Blockade | The primary outcome will be duration of sensory blockade in the distribution of the lumbar plexus as determined by pin-prick sensation as tested every two hours with pin-prick sensation. | 30 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Analgesic Request | Time (in minutes) will be recorded to first analgesic request following the block placement | 30 hours |
| Total Opioid Consumption | 30 hours |
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Inclusion Criteria: Primary elective total hip arthroplasty surgery
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daryl S Henshaw, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29406180 | Derived | Turner JD, Dobson SW, Weller RS, Russell GB, Henshaw DS. Intravenous dexamethasone fails to prolong psoas compartment block when assessed by objective pinprick sensory testing: a prospective, randomised, dose-dependent, placebo-controlled equivalency trial. Br J Anaesth. 2018 Feb;120(2):308-316. doi: 10.1016/j.bja.2017.11.073. Epub 2017 Dec 1. |
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Patients 18-90 years old undergoing primary elective total hip arthroplasty were eligible. Exclusion: contraindications to regional anaesthesia, peripheral neurologic dysfunction or neuropathy, diabetes mellitus, systemic corticosteroid use within 30-days of surgery, chronic opioid use, pregnancy, allergy or adverse reaction to dexamethasone.
Study run from June 2015 to January 2017 at Wake Forest Baptist Medical Center
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| ID | Title | Description |
|---|---|---|
| FG000 | 4 mg Dexamethasone Group | Following lumbar plexus nerve block administration using bupivacaine and epinephrine, 4 mg of systemic dexamethasone will be administered to this group intravenously. The volume given intravenously will be identical for all groups. |
| FG001 | 8 mg Dexamethasone Group | Following peripheral nerve block using bupivacaine and epinephrine administration, 8 mg of systemic dexamethasone will be administered to this group intravenously. The volume given intravenously will be identical for all groups. |
| FG002 | Control Group | Normal saline will be used as a placebo control group given at the same time and in the same manner as the experimental groups following peripheral nerve block administration. The volume given intravenously will be identical for all groups. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 4 mg Dexamethasone Group | Following lumbar plexus nerve block administration using bupivacaine and epinephrine, 4 mg of systemic dexamethasone will be administered to this group intravenously. The volume given intravenously will be identical for all groups. Dexamethasone: A lumbar plexus nerve block will be performed for patients undergoing hip arthroplasty. A total of 25cc's of 0.25% bupivacaine with 1:400,000 epinephrine will be administered for postoperative analgesia. Surgical anesthesia will be provided either by an intrathecal spinal block or general anesthesia. The block will be tested for block success. Testing will be performed with a 25 gauge Whitacre needle . The subjects will then receive dexamethasone (4 or 8 mg) or placebo (saline) based on arm placement. Bupivacaine: Bupivacaine will be used in lumbar plexus nerve block mixture. Epinephrine: Epinephrine will be used in lumbar plexus nerve block mixture. Lumbar Plexus Nerve Block: This is the procedure that will be performed. |
| 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 Sensory Blockade | The primary outcome will be duration of sensory blockade in the distribution of the lumbar plexus as determined by pin-prick sensation as tested every two hours with pin-prick sensation. | Posted | Mean | Standard Deviation | hours | 30 hours |
|
Each participant was specifically monitored over a 30 hour time period while in the hospital and encouraged to report and adverse events while in the hospital or after while the study was being conducted.
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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 | 4 mg Dexamethasone Group | Following lumbar plexus nerve block administration using bupivacaine and epinephrine, 4 mg of systemic dexamethasone will be administered to this group intravenously. The volume given intravenously will be identical for all groups. Dexamethasone: A lumbar plexus nerve block will be performed for patients undergoing hip arthroplasty. A total of 25cc's of 0.25% bupivacaine with 1:400,000 epinephrine will be administered for postoperative analgesia. Surgical anesthesia will be provided either by an intrathecal spinal block or general anesthesia. Successful blockade will be assumed if the patient has a decrease or loss of pinprick sensation in the femoral nerve distribution, which innervates the anterior thigh. If no evidence of blockade is present, testing will occur again at 30 minutes post block. Testing will be performed with a 25 gauge Whitacre needle |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. James D. Turner | Wake Forest Baptist Medical Center | 3367164998 | jturner@wakehealth.edu |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| C004180 | dexamethasone 21-phosphate |
| D002045 | Bupivacaine |
| D004837 | Epinephrine |
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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|
|
| Bupivacaine | Drug | Bupivacaine will be used in lumbar plexus nerve block mixture. |
|
|
| Epinephrine | Drug | Epinephrine will be used in lumbar plexus nerve block mixture. |
|
|
| Lumbar Plexus Nerve Block | Procedure | This is the procedure that will be performed. |
|
| Saline | Drug | Patients randomized to the placebo group will receive normal saline intravenously. |
|
|
| Verbal Numeric Pain Score Comparisons | This secondary outcome includes pain scores utilizing the verbal numeric pain score scale (0 to 11). Higher values indicate worse outcomes (higher pain scores). Lower values are better. | 24 hour |
| BG001 | 8 mg Dexamethasone Group | Following peripheral nerve block using bupivacaine and epinephrine administration, 8 mg of systemic dexamethasone will be administered to this group intravenously. The volume given intravenously will be identical for all groups. Dexamethasone: A lumbar plexus nerve block will be performed for patients undergoing hip arthroplasty. A total of 25cc's of 0.25% bupivacaine with 1:400,000 epinephrine will be administered for postoperative analgesia. Surgical anesthesia will be provided either by an intrathecal spinal block or general anesthesia. The block will be tested for block success. Testing will be performed with a 25 gauge Whitacre needle . The subjects will then receive dexamethasone (4 or 8 mg) or placebo (saline) based on arm placement. Bupivacaine: Bupivacaine will be used in lumbar plexus nerve block mixture. Epinephrine: Epinephrine will be used in lumbar plexus nerve block mixture. Lumbar Plexus Nerve Block: This is the procedure that will be performed. |
| BG002 | Control Group | Normal saline will be used as a placebo control group given at the same time and in the same manner as the experimental groups following peripheral nerve block administration. The volume given intravenously will be identical for all groups. Bupivacaine: Bupivacaine will be used in lumbar plexus nerve block mixture. Epinephrine: Epinephrine will be used in lumbar plexus nerve block mixture. Lumbar Plexus Nerve Block: This is the procedure that will be performed. Saline: Patients randomized to the placebo group will receive normal saline intravenously. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Median | Inter-Quartile Range | kg/m^2 |
|
| OG001 | 8 mg Dexamethasone Group | Following peripheral nerve block using bupivacaine and epinephrine administration, 8 mg of systemic dexamethasone will be administered to this group intravenously. The volume given intravenously will be identical for all groups. Dexamethasone: A lumbar plexus nerve block will be performed for patients undergoing hip arthroplasty. A total of 25cc's of 0.25% bupivacaine with 1:400,000 epinephrine will be administered for postoperative analgesia. Surgical anesthesia will be provided either by an intrathecal spinal block or general anesthesia. Successful blockade will be assumed if the patient has a decrease or loss of pinprick sensation in the femoral nerve distribution, which innervates the anterior thigh. If no evidence of blockade is present, testing will occur again at 30 minutes post block. Testing will be performed with a 25 gauge Whitacre needle and once present the area of testing will be marked with a surgical marking pen so that repeat sensory testing can be undertaken |
| OG002 | Control Group | Normal saline will be used as a placebo control group given at the same time and in the same manner as the experimental groups following peripheral nerve block administration. The volume given intravenously will be identical for all groups. Bupivacaine: Bupivacaine will be used in lumbar plexus nerve block mixture. Epinephrine: Epinephrine will be used in lumbar plexus nerve block mixture. Lumbar Plexus Nerve Block: This is the procedure that will be performed. Saline: Patients randomized to the placebo group will receive normal saline intravenously. |
|
|
| Secondary | Time to First Analgesic Request | Time (in minutes) will be recorded to first analgesic request following the block placement | Posted | Median | Inter-Quartile Range | minutes | 30 hours |
|
|
|
| Secondary | Total Opioid Consumption | Posted | Median | Inter-Quartile Range | oxycodone mg equivalents | 30 hours |
|
|
|
| Secondary | Verbal Numeric Pain Score Comparisons | This secondary outcome includes pain scores utilizing the verbal numeric pain score scale (0 to 11). Higher values indicate worse outcomes (higher pain scores). Lower values are better. | Posted | Median | Inter-Quartile Range | scores on a scale | 24 hour |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | 8 mg Dexamethasone Group | Following peripheral nerve block using bupivacaine and epinephrine administration, 8 mg of systemic dexamethasone will be administered to this group intravenously. The volume given intravenously will be identical for all groups. Dexamethasone: A lumbar plexus nerve block will be performed for patients undergoing hip arthroplasty. A total of 25cc's of 0.25% bupivacaine with 1:400,000 epinephrine will be administered for postoperative analgesia. Surgical anesthesia will be provided either by an intrathecal spinal block or general anesthesia. Successful blockade will be assumed if the patient has a decrease or loss of pinprick sensation in the femoral nerve distribution, which innervates the anterior thigh. If no evidence of blockade is present, testing will occur again at 30 minutes post block. Testing will be performed with a 25 gauge Whitacre needle and once present the area of testing will be marked with a surgical marking pen so that repeat sensory testing can be undertaken | 0 | 50 | 0 | 50 |
| EG002 | Control Group | Normal saline will be used as a placebo control group given at the same time and in the same manner as the experimental groups following peripheral nerve block administration. The volume given intravenously will be identical for all groups. Bupivacaine: Bupivacaine will be used in lumbar plexus nerve block mixture. Epinephrine: Epinephrine will be used in lumbar plexus nerve block mixture. Lumbar Plexus Nerve Block: This is the procedure that will be performed. Saline: Patients randomized to the placebo group will receive normal saline intravenously. | 0 | 15 | 0 | 15 |
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| D012216 |
| Rheumatic Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |