Spine Surgery
Conditions
Keywords
Spine Surgery, Intraocular pressure, Lidocaine, Epidural Anesthetic
Brief summary
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.
Detailed description
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.
Interventions
DRUGLidocaine
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
DRUGplacebo
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
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 18 to 75 years old at time of surgery - adult patients differ from pediatric patients in that adult spines are stiffer than pediatric patient. * Elective spine surgery * Two levels laminectomies or above with or without fusion or instrumentatioN * General anesthesia * Surgery performed at Cleveland Clinic with informed consent signed prior to sedation or anesthesia - consistent surgical team
Exclusion criteria
* contraindication to lidocaine such as substantial hepatic impairment (ALT or AST more than twice normal) * renal impairment (serum creatinine \>2 mg/dl), * seizure disorder requiring medication within 2 years * planned epidural anesthesia or analgesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Pain Scores | From admission to the post anesthesia care unit through postoperative day 2 (or discharge, if earlier). | 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). |
| Opioid Medication Requirement, mg in IV Morphine Equivalent | through postoperative day 2 (or discharge, if earlier) | Opioid consumption during the initial 48 postoperative hours was converted to IV morphine sulfate equivalents |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Any Major 30-day Post Operative Complications | 30 days after surgery | 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. |
| Postoperative Nausea and Vomiting (PONV) | post op day one and two or till hospital discharge | Postoperative Nausea and Vomiting (PONV)will be noted during day one and day two postoperative. |
| Duration of Hospitalization | At discharge | Length of hospital stay will be recorded in days. |
| 12-item Short Form Survey (SF-12) Physical Health Composite Score | 30 days post operative | 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. |
Countries
United States
Participant flow
Recruitment details
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 .
Participants by arm
| Arm | Count |
|---|---|
| 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 | 57 |
| Placebo Perioperative equal volume of saline placebo IV infusion | 58 |
| Total | 115 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Lidocaine | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 58 years STANDARD_DEVIATION 11 | 54 years STANDARD_DEVIATION 11 | 56 years STANDARD_DEVIATION 11 |
| Gender Female | 22 Participants | 23 Participants | 45 Participants |
| Gender Male | 35 Participants | 35 Participants | 70 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 57 | 0 / 58 |
| serious Total, serious adverse events | 0 / 57 | 0 / 58 |
Outcome results
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).
Time frame: From admission to the post anesthesia care unit through postoperative day 2 (or discharge, if earlier).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lidocaine | Mean Pain Scores | 4.4 verbal response scores | Standard Deviation 0.13 |
| Placebo | Mean Pain Scores | 5.3 verbal response scores | Standard Deviation 0.13 |
Comparison: Postoperative analgesia was characterized using both pain scores and opioid consumption .We considered one of the groups to be better than the other on postoperative pain control with superiority on either outcome, in the presence of noninferiority on both outcomes. Thus, our primary hypothesis was assessed in a joint hypothesis testing framework .p-value: <0.00197.5% CI: [-1.23, -0.4]Mixed Models Analysis
Primary
Opioid Medication Requirement, mg in IV Morphine Equivalent
Opioid consumption during the initial 48 postoperative hours was converted to IV morphine sulfate equivalents
Time frame: through postoperative day 2 (or discharge, if earlier)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lidocaine | Opioid Medication Requirement, mg in IV Morphine Equivalent | 55 mg IV morphine equivalent | Standard Deviation 8 |
| Placebo | Opioid Medication Requirement, mg in IV Morphine Equivalent | 74 mg IV morphine equivalent | Standard Deviation 11 |
Comparison: Postoperative analgesia was characterized using both pain scores and opioid consumption .We considered one of the groups to be better than the other on postoperative pain control with superiority on either outcome, in the presence of noninferiority on both outcomes. Thus, our primary hypothesis was assessed in a joint hypothesis testing framework .p-value: 0.01195% CI: [0.65, 1.21]Regression, Linear
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.
Time frame: 90 days post operative
Population: Include the participants who finished the Acute SF 12 health survey at 90 days follow-up
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lidocaine | 12-item Short Form Survey (SF-12) Physical Health Composite Score | 39 units on a scale |
| Placebo | 12-item Short Form Survey (SF-12) Physical Health Composite Score | 34 units on a scale |
p-value: 0.0495% CI: [0.3, 8.9]Regression, Logistic
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.
Time frame: 30 days post operative
Population: Include the participants who finished the Acute SF 12 health survey at 30 days follow-up
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lidocaine | 12-item Short Form Survey (SF-12) Physical Health Composite Score | 38 units on a scale |
| Placebo | 12-item Short Form Survey (SF-12) Physical Health Composite Score | 33 units on a scale |
p-value: 0.00295% CI: [2.3, 10]Regression, Linear
Secondary
Duration of Hospitalization
Length of hospital stay will be recorded in days.
Time frame: At discharge
Population: 3 patients in the placebo group did not have duration of hospital stay recorded.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lidocaine | Duration of Hospitalization | 3 days |
| Placebo | Duration of Hospitalization | 3 days |
p-value: 0.1595% CI: [-2.4, 0.4]Regression, Linear
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.
Time frame: 30 days after surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lidocaine | Number of Participants With Any Major 30-day Post Operative Complications | 2 participants |
| Placebo | Number of Participants With Any Major 30-day Post Operative Complications | 5 participants |
p-value: 0.04995% CI: [0.84, 1]Regression, Logistic
Secondary
Postoperative Nausea and Vomiting (PONV)
Postoperative Nausea and Vomiting (PONV)will be noted during day one and day two postoperative.
Time frame: post op day one and two or till hospital discharge
Population: We only have 39 and 36 patients for comparison of PONV at day two after surgery, since the rest were discharged by that time
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lidocaine | Postoperative Nausea and Vomiting (PONV) | Nausea | 4 participants |
| Lidocaine | Postoperative Nausea and Vomiting (PONV) | Vomiting | 2 participants |
| Placebo | Postoperative Nausea and Vomiting (PONV) | Vomiting | 1 participants |
| Placebo | Postoperative Nausea and Vomiting (PONV) | Nausea | 8 participants |
Comparison: Nausea - POD 2p-value: 0.3195% CI: [0.77, 1.09]Regression, Logistic
Comparison: Vomiting - POD 2p-value: 0.4495% CI: [0.94, 1.14]Regression, Logistic