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Drug was discontinued by manufacturer
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| Name | Class |
|---|---|
| EKR Therapeutics, Inc | INDUSTRY |
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At Wake Forest University, the investigators have been using Extended Release Epidural Morphine (EREM), since late 2004, as part of multimodal analgesia in patients having gynecologic surgeries and hip arthroplasties.
Hypothesis:
In patients undergoing a Birmingham total hip arthroplasty (BHA), low dose EREM in conjunction with lumbar plexus block (LPB) will be better than lumbar plexus block alone in increasing proportion of patients who meet discharge criteria within 24 hours.
Extended release epidural morphine (EREM, DepoDur®: Endo Pharmaceuticals, Chadds Ford PA) has been studied and increasingly utilized as a method to allow for the improved post-operative analgesia of epidural analgesia without infusions.
At Wake Forest University, the investigators have been using EREM, since late 2004, as part of multimodal analgesia in patients having gynecologic surgeries and hip arthroplasties. The investigators initially decreased our dosages from those recommended (15 mg for lower extremity surgery and 10-15 mg for abdominal surgery), because side effects (nausea, vomiting and hypotension) were felt to be limiting to recovery. The investigators now use 4-7.5 mg in most patients, with 7.5 mg being the exception and have achieved better results. For hip arthroplasties, the investigators currently use 4-5 mg and have performed two retrospective chart reviews on this use; both suggesting that this approach is efficacious. However, these doses have not been studied in a prospective, randomized, double blind trial. The investigators would like to evaluate the efficacy of this dose of EREM used as part of a multimodal regimen. The investigators will compare EREM 4 mg with lumbar plexus block versus lumbar plexus block alone, (providing the rest of our multimodal approach for both patients).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extended Release Epidural Morphine | Experimental | Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline |
|
| Placebo Group | Placebo Comparator | The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extended Release Epidural Morphine (EREM) | Drug | A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline |
|
| Measure | Description | Time Frame |
|---|---|---|
| Length of Hospital Stay After Surgery | From surgery day to hospital discharge, up to 4 days |
| Measure | Description | Time Frame |
|---|---|---|
| Total Opioid Consumption | Postoperatively, the patients were observed in the post anesthesia care unit (PACU) until regression of sensory levels is demonstrated. They were provided an intravenous (IV) Patient Controlled Analgesia (PCA) and instructions in its use. Morphine 1mg/ml at standard PCA settings (1.5 ml dose, 10 minute lockout interval, 6 ml hourly limit, no basal infusion) were used for postoperative analgesia until discharge plans were made. (Morphine doses were increased in 0.5ml dose increments if the patients were not achieving adequate analgesia.) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pamela C Nagle, M.D. | 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 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Extended Release Epidural Morphine | Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline Extended Release Epidural Morphine (EREM): A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline |
| FG001 | Placebo Group | The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush Placebo: A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Extended Release Epidural Morphine | Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline Extended Release Epidural Morphine (EREM): A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline |
| BG001 |
| 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 | Length of Hospital Stay After Surgery | Posted | Mean | Standard Deviation | Days | From surgery day to hospital discharge, up to 4 days |
|
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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 | Extended Release Epidural Morphine | Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline Extended Release Epidural Morphine (EREM): A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Blood and lymphatic system disorders | Hypotension | Non-systematic Assessment | Subject experienced hypotension during the operative period, continued to experience hypotension during the immediate recovery period and continued on the neosynephrine infusion as well as receiving blood products and colloids for fluid resuscitation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Pamela Nagle Assistant Professor | Anesthesiology | 336-716-7180 |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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|
| Placebo | Drug | A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush |
|
|
| 96 hours |
| Patient Satisfaction Score | Verbal satisfaction scores (0-10), higher scores represent better outcomes. Scores will be obtained from patients for 96 hours after surgery. | 96 hours |
| Distance Walked at Walking Test | Distance walked at walking test. Longer distance walked represent better outcomes | 96 hours |
| Verbal Pain Scores Post-gait | Verbal pain scores (0-10), lower scores represent better outcomes. Score will be obtained from patients for 1 day after surgery, post gait active and at rest. | 1 day post surgery |
| Verbal Pain Scores Post-gait | Verbal pain scores (0-10), lower scores represent better outcomes. Score will be obtained from patients for 1 day after surgery, post gait active and at rest. | 2 Days Post Surgery |
| Verbal Pain Scores Post-gait | Verbal pain scores (0-10), lower scores represent better outcomes. Score will be obtained from patients for 1 day after surgery, post gait active and at rest. | 3 Days Post Surgery |
| Verbal Pain Scores Post-gait | Verbal pain scores (0-10), lower scores represent better outcomes. Score will be obtained from patients for 1 day after surgery, post gait active and at rest. | 4 Days Post Surgery |
| Placebo Group |
The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush Placebo: A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Total Opioid Consumption | Postoperatively, the patients were observed in the post anesthesia care unit (PACU) until regression of sensory levels is demonstrated. They were provided an intravenous (IV) Patient Controlled Analgesia (PCA) and instructions in its use. Morphine 1mg/ml at standard PCA settings (1.5 ml dose, 10 minute lockout interval, 6 ml hourly limit, no basal infusion) were used for postoperative analgesia until discharge plans were made. (Morphine doses were increased in 0.5ml dose increments if the patients were not achieving adequate analgesia.) | Data not collected on Extended Release Epidural Morphine group | Posted | Mean | Standard Deviation | mg | 96 hours |
|
|
|
| Secondary | Patient Satisfaction Score | Verbal satisfaction scores (0-10), higher scores represent better outcomes. Scores will be obtained from patients for 96 hours after surgery. | 17 participants in the Extended Release Epidural Morphine group and 18 participants in the placebo group provided Verbal satisfaction scores | Posted | Mean | Standard Deviation | units on a scale | 96 hours |
|
|
|
| Secondary | Distance Walked at Walking Test | Distance walked at walking test. Longer distance walked represent better outcomes | Different amount of observations were different at each visit. Data for Post Surgery Day 4 for the "Extended Release Epidural Morphine" was not collected. | Posted | Mean | Standard Deviation | Steps | 96 hours |
|
|
|
| Secondary | Verbal Pain Scores Post-gait | Verbal pain scores (0-10), lower scores represent better outcomes. Score will be obtained from patients for 1 day after surgery, post gait active and at rest. | 16 participants were analyzed in both the Extended Release Epidural Morphine and the Placebo Group for active pain scores. 17 participants overall were analyzed for the Extended Release Epidural Morphine and 18 participants overall were analyzed for the Placebo Group. | Posted | Mean | Standard Deviation | units on a scale | 1 day post surgery |
|
|
|
| Secondary | Verbal Pain Scores Post-gait | Verbal pain scores (0-10), lower scores represent better outcomes. Score will be obtained from patients for 1 day after surgery, post gait active and at rest. | Posted | Mean | Standard Deviation | units on a scale | 2 Days Post Surgery |
|
|
|
| Secondary | Verbal Pain Scores Post-gait | Verbal pain scores (0-10), lower scores represent better outcomes. Score will be obtained from patients for 1 day after surgery, post gait active and at rest. | Posted | Mean | Standard Deviation | units on a scale | 3 Days Post Surgery |
|
|
|
| Secondary | Verbal Pain Scores Post-gait | Verbal pain scores (0-10), lower scores represent better outcomes. Score will be obtained from patients for 1 day after surgery, post gait active and at rest. | Posted | Mean | Standard Deviation | units on a scale | 4 Days Post Surgery |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Placebo Group | The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush Placebo: A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush | 0 | 20 | 0 | 20 | 1 | 20 |
|
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| D017670 |
| Sodium Compounds |
| Post Day 1 Surgery |
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| Post Day 2 Surgery |
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| Post Day 3 Surgery |
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| Post Day 4 Surgery |
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| Post Surgery Day 2 |
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| Post Surgery Day 3 |
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| Post Surgery Day 4 |
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| Pain Score at Rest |
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