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This study has been designed as a controlled clinical trial to evaluate the efficacy of brief lidocaine infusion, brief ketamine infusion and a lidocaine/ketamine combined infusion when added to conventional opioid therapy following major spine surgery, as well as to evaluate the effects of the lidocaine/ketamine pain protocol on the feasibility of performing routine intraoperative neurophysiology during spine surgery in adults and determine whether this infusion protocol is compatible with intraoperative neurophysiology on spine surgery patients. If one or more of the approaches is confirmed as efficacious and safe, it could have a significant impact on the routine management of postoperative pain in this context.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine | Experimental | Ketamine infused at 0.25 mg/kg/hour. |
|
| Lidocaine | Experimental | Lidocaine infused at 0.5 mg/kg/hour. |
|
| Ketamine and Lidocaine | Experimental | Ketamine infused at 0.25 mg/kg/hour along with lidocaine at 0.5 mg/kg/hour |
|
| Placebo | Placebo Comparator | Placebo (saline) given to compare usual treatment against active agents in post operative pain management. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug |
| ||
| Ketamine |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity | The primary outcome will be average pain intensity at rest on postoperative day 1 - 3. Pain Intensity rated from 0 (none) to 10 (severe). | postoperative day 1 - 3 |
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Inclusion Criteria:
Male and Female >/= 18 years of age Patients undergoing first-time fusion surgery or surgery to revise a prior fusion Able to read, write and speak in English, and able to give informed consent for the study
Exclusion Criteria:
Any disease associated with major organ dysfunction renal dysfunction hepatic dysfunction cardiac dysfunction
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| Name | Affiliation | Role |
|---|---|---|
| Ronald Kaplan, MD | Beth Israel Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Medical Center | New York | New York | 10003 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ketamine | Ketamine infused at 0.25 mg/kg/hour. Ketamine |
| FG001 | Lidocaine | Lidocaine infused at 0.5 mg/kg/hour. Lidocaine |
| FG002 | Ketamine and Lidocaine | Ketamine infused at 0.25 mg/kg/hour along with lidocaine at 0.5 mg/kg/hour Lidocaine Ketamine |
| FG003 | Placebo | Placebo (saline) given to compare usual treatment against active agents in post operative pain management. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ketamine | Ketamine infused at 0.25 mg/kg/hour. Ketamine |
| BG001 | Lidocaine | Lidocaine infused at 0.5 mg/kg/hour. Lidocaine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Intensity | The primary outcome will be average pain intensity at rest on postoperative day 1 - 3. Pain Intensity rated from 0 (none) to 10 (severe). | Posted | Mean | Standard Deviation | units on a scale | postoperative day 1 - 3 |
|
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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 | Ketamine infused at 0.25 mg/kg/hour. Ketamine |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diplopia | Eye disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ronald Kaplan, MD | Beth Israel Medical Center | rkaplan@chpnet.org |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D007649 | Ketamine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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|
| Saline | Other |
|
| BG002 | Ketamine and Lidocaine | Ketamine infused at 0.25 mg/kg/hour along with lidocaine at 0.5 mg/kg/hour Lidocaine Ketamine |
| BG003 | Placebo | Placebo (saline) given to compare usual treatment against active agents in post operative pain management. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG003 | Placebo | Placebo (saline) given to compare usual treatment against active agents in post operative pain management. |
|
|
| 1 |
| 12 |
| 2 |
| 12 |
| EG001 | Lidocaine | Lidocaine infused at 0.5 mg/kg/hour. Lidocaine | 0 | 11 | 2 | 11 |
| EG002 | Ketamine and Lidocaine | Ketamine infused at 0.25 mg/kg/hour along with lidocaine at 0.5 mg/kg/hour Lidocaine Ketamine | 3 | 12 | 6 | 12 |
| EG003 | Placebo | Placebo (saline) given to compare usual treatment against active agents in post operative pain management. | 1 | 11 | 6 | 11 |
| Respiratory Depression | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Low Blood Pressure | Cardiac disorders | Systematic Assessment |
|
| Cold Sweats | General disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Sedation | General disorders | Systematic Assessment |
|
| Confusion | Psychiatric disorders | Systematic Assessment |
|
| Paranoia | Psychiatric disorders | Systematic Assessment |
|
| Blurred Vision | Eye disorders | Systematic Assessment |
|
| Lightheadedness | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Itching | General disorders | Systematic Assessment |
|
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |