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The purpose of this study is determine if epidural anesthesia administered after surgery or lidocaine administered during surgery will decrease inflammation after spinal surgery and decrease the need for post operative pain medication compared to intravenous patient controlled analgesia. Participants undergoing spine surgery will be randomized into one of two groups;
- A.) General Anesthesia and postoperative Patient Controlled Analgesia and placebo IV infusion.
B.) General Anesthesia plus perioperative intravenous lidocaine infusion, and post operative Patient Controlled Analgesia.
According to a survey of 1570 U.S neurosurgeons, in the United States about 527.000 spine surgeries were done in 1999. This represents close to 65% of the procedures performed by neurosurgeons. Furthermore, the number of hospitalizations related with spine surgery has significantly increased since 1970.
IV PCA is considered the standard of care for postoperative pain control after surgery. Intravenous opioids have significant side effects such as respiratory depression, postoperative nausea and vomiting and sedation. Furthermore, they cause delayed return of bowel function and ileus.
There is the possibility of surgically inserting a catheter into the epidural space at the end of surgery. In general epidural analgesia provides excellent pain relief after surgery and decreases opioid consumption significantly und thus opioid related postoperative complications. Furthermore epidural anesthesia affects the surgical stress response and might decrease inflammatory responses after surgery, thereby improving postoperative recovery and mobilization of the patients.
Intravenous local anesthetics have potent anti-inflammatory properties. They also decrease postoperative opioid consumption. Clinical studies have shown that perioperative local anesthetic administration significantly reduces the incidence of thrombosis and postoperative pain, shortens postoperative ileus and decreases duration of hospitalization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Perioperative placebo IV infusion besides the standard anesthesia care, including general anesthesia and postoperative patient controlled analgesia. |
|
| Lidocaine | Active Comparator | Perioperative intravenous lidocaine infusion besides the standard anesthesia care, including general anesthesia plus and post operative patient controlled analgesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Pain Scores | The pain score as measured by verbal response scores (scale ranging from 0 to 10 with 0=no pain; 10=worst pain) every 30 minutes during post anesthesia care unit stay, then per nursing floor protocol (roughly every 4-6 hours). | From admission to the post anesthesia care unit through postoperative day 2 (or discharge, if earlier). |
| Opioid Medication Requirement, mg in IV Morphine Equivalent | Opioid consumption during the initial 48 postoperative hours was converted to IV morphine sulfate equivalents | through postoperative day 2 (or discharge, if earlier) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Any Major 30-day Post Operative Complications | The occurrence in an individual of one or more the following major complications, including pneumonia, respiratory failure, prolonged use or need for reinsertion of chest tube, cardiac arrest, arrhythmia, congestive heart failure, stroke, intravascular coagulopathy, thromboembolic disease (pulmonary embolism), injury to great vessels, delirium, monoplegia or paraplegia, upper gastrointestinal bleeding, gastrointestinal block, ureteral obstruction, syndrome of inappropriate antidiruretic hormone secretion, wound infection requiring debridement, sepsis, and readmission. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ehab Farag, MD | The Cleveland Clinic | Principal Investigator |
| Daniel I Sessler, MD | The Cleveland Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
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With approval of the institutional review board at the Cleveland Clinic and written informed consent, between September 2009 to October 2011 we enrolled 116 patients to undergo elective multi-level spine surgery At Cleveland Clinic, Cleveland, Ohio, USA .
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| ID | Title | Description |
|---|---|---|
| FG000 | Lidocaine | Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours |
| FG001 | Placebo | Perioperative equal volume of saline placebo IV infusion |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Lidocaine | Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours |
| BG001 | Placebo |
| 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 | Mean Pain Scores | The pain score as measured by verbal response scores (scale ranging from 0 to 10 with 0=no pain; 10=worst pain) every 30 minutes during post anesthesia care unit stay, then per nursing floor protocol (roughly every 4-6 hours). | Posted | Mean | Standard Deviation | verbal response scores | From admission to the post anesthesia care unit through postoperative day 2 (or discharge, if earlier). |
|
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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 | Lidocaine | Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roberta Johnson | Cleveland Clinic | 216-444-9950 | johnsor13@ccf.org |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| placebo | Drug | perioperative placebo IV saline infusion of 2 mg/kg/h with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours |
|
| 30 days after surgery |
| Postoperative Nausea and Vomiting (PONV) | Postoperative Nausea and Vomiting (PONV)will be noted during day one and day two postoperative. | post op day one and two or till hospital discharge |
| Duration of Hospitalization | Length of hospital stay will be recorded in days. | At discharge |
| 12-item Short Form Survey (SF-12) Physical Health Composite Score | Physical health composite score ranges from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. | 30 days post operative |
| 12-item Short Form Survey (SF-12) Physical Health Composite Score | Physical health composite score ranges from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. | 90 days post operative |
Perioperative equal volume of saline placebo IV infusion
| BG002 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
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| Primary | Opioid Medication Requirement, mg in IV Morphine Equivalent | Opioid consumption during the initial 48 postoperative hours was converted to IV morphine sulfate equivalents | Posted | Mean | Standard Deviation | mg IV morphine equivalent | through postoperative day 2 (or discharge, if earlier) |
|
|
|
|
| Secondary | Number of Participants With Any Major 30-day Post Operative Complications | The occurrence in an individual of one or more the following major complications, including pneumonia, respiratory failure, prolonged use or need for reinsertion of chest tube, cardiac arrest, arrhythmia, congestive heart failure, stroke, intravascular coagulopathy, thromboembolic disease (pulmonary embolism), injury to great vessels, delirium, monoplegia or paraplegia, upper gastrointestinal bleeding, gastrointestinal block, ureteral obstruction, syndrome of inappropriate antidiruretic hormone secretion, wound infection requiring debridement, sepsis, and readmission. | Posted | Number | participants | 30 days after surgery |
|
|
|
|
| Secondary | Postoperative Nausea and Vomiting (PONV) | Postoperative Nausea and Vomiting (PONV)will be noted during day one and day two postoperative. | We only have 39 and 36 patients for comparison of PONV at day two after surgery, since the rest were discharged by that time | Posted | Number | participants | post op day one and two or till hospital discharge |
|
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| Secondary | Duration of Hospitalization | Length of hospital stay will be recorded in days. | 3 patients in the placebo group did not have duration of hospital stay recorded. | Posted | Median | Inter-Quartile Range | days | At discharge |
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|
|
| Secondary | 12-item Short Form Survey (SF-12) Physical Health Composite Score | Physical health composite score ranges from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. | Include the participants who finished the Acute SF 12 health survey at 30 days follow-up | Posted | Median | Inter-Quartile Range | units on a scale | 30 days post operative |
|
|
|
|
| Secondary | 12-item Short Form Survey (SF-12) Physical Health Composite Score | Physical health composite score ranges from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. | Include the participants who finished the Acute SF 12 health survey at 90 days follow-up | Posted | Median | Inter-Quartile Range | units on a scale | 90 days post operative |
|
|
|
|
| 0 |
| 57 |
| 0 |
| 57 |
| EG001 | Placebo | Perioperative equal volume of saline placebo IV infusion | 0 | 58 | 0 | 58 |
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| Aniline Compounds |
| D000588 | Amines |
| Yes |
| Non-Inferiority or Equivalence |
Non-inferiority margin: ratio of the geometric means not more than 1.3 greater (mean mg IV morphine equivalent not more than 30% greater ) than that of the other group |
| 0.44 |
| Odds Ratio (OR) |
| 1.04 |
| 2-Sided |
| 95 |
| 0.94 |
| 1.14 |
| No |
| Superiority or Other |