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The study was unable to enroll efficiently despite trying various technique.
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The purpose of this study is to determine whether epidural and ketamine infusions are effective in the treatment of Complex Regional Pain Syndrome (CRPS).
Potential patients must clear all study requirements to be enrolled. Study requirements include labwork, psychiatric evaluation, and cardiology evaluation.
Once enrolled, patients will be in one of two groups:
The patient and study staff are blinded.
This study requires multiple visits to Hospital for Special Surgery in New York City over the course of three months and concludes with a final visit after six months. The study will only cover costs associated with the scheduled in-patient and out-patient visits. The study patient will be responsible for all other costs (including travel and hotel accommodations) that he/she may incur for participating in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine Infusion + Epidural Infusion + Booster Infusion | Experimental | Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of KETAMINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion. Outpatient: Patients will receive three ketamine booster infusions over the course of three months. |
|
| Control Group + Epidural Infusion + Booster Infusion | Placebo Comparator | Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of SALINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion. Outpatient: Patients will receive three saline booster infusions over the course of three months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine Infusion + Epidural Infusion | Drug | The ketamine and epidural infusions will be administered over 96 hours with appropriate titration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Reduction | Evidence of changes in NRS pain scores between baseline and six months post infusion | 6 months post infusion |
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INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel I Richman, MD | 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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| Label | URL |
|---|---|
| Hospital for Special Surgery | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ketamine Infusion + Epidural Infusion + Booster Infusion | Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of KETAMINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion. Outpatient: Patients will receive three ketamine booster infusions over the course of three months. Ketamine Infusion + Epidural Infusion: The ketamine and epidural infusions will be administered over 96 hours with appropriate titration. Ketamine Booster Infusion: Patients will receive three ketamine booster infusions over the course of three months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Control Group + Epidural infusion | Drug | The saline and epidural infusions will be administered over 96 hours with appropriate titration. |
|
|
| Ketamine Booster Infusion | Drug | Patients will receive three ketamine booster infusions over the course of three months. |
|
|
| Control Group Booster Infusion | Drug | Patients will receive three saline booster infusions over the course of three months. |
|
|
| FG001 | Control Group + Epidural Infusion + Booster Infusion | Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of SALINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion. Outpatient: Patients will receive three saline booster infusions over the course of three months. Control Group + Epidural infusion: The saline and epidural infusions will be administered over 96 hours with appropriate titration. Control Group Booster Infusion: Patients will receive three saline booster infusions over the course of three months. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ketamine Infusion + Epidural Infusion + Booster Infusion | Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of KETAMINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion. Outpatient: Patients will receive three ketamine booster infusions over the course of three months. Ketamine Infusion + Epidural Infusion: The ketamine and epidural infusions will be administered over 96 hours with appropriate titration. Ketamine Booster Infusion: Patients will receive three ketamine booster infusions over the course of three months. |
| BG001 | Control Group + Epidural Infusion + Booster Infusion | Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of SALINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion. Outpatient: Patients will receive three saline booster infusions over the course of three months. Control Group + Epidural infusion: The saline and epidural infusions will be administered over 96 hours with appropriate titration. Control Group Booster Infusion: Patients will receive three saline booster infusions over the course of three months. |
| BG002 | Total | Total of all reporting groups |
| 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 | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Pain Reduction | Evidence of changes in NRS pain scores between baseline and six months post infusion | Study terminated early due to lack of enrollment. We did not analyze any data. | Posted | 6 months post infusion |
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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 | Ketamine Infusion + Epidural Infusion + Booster Infusion | Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of KETAMINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion. Outpatient: Patients will receive three ketamine booster infusions over the course of three months. Ketamine Infusion + Epidural Infusion: The ketamine and epidural infusions will be administered over 96 hours with appropriate titration. Ketamine Booster Infusion: Patients will receive three ketamine booster infusions over the course of three months. | 0 | 2 | 0 | 2 | ||
| EG001 | Control Group + Epidural Infusion + Booster Infusion | Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of SALINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion. Outpatient: Patients will receive three saline booster infusions over the course of three months. Control Group + Epidural infusion: The saline and epidural infusions will be administered over 96 hours with appropriate titration. Control Group Booster Infusion: Patients will receive three saline booster infusions over the course of three months. | 0 | 1 | 0 | 1 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Richman | HSS | 212.517.4481 | RichmanD@HSS.EDU |
| ID | Term |
|---|---|
| D020918 | Complex Regional Pain Syndromes |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| D007268 | Injections, Epidural |
| D035061 | Control Groups |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D007278 | Injections, Spinal |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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| >=65 years |
|
| Male |
|