An interventional study of Lidocaine and placebo in Spine Surgery, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-12-23.
Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Treatment
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;
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.
The Cleveland Clinic is the lead sponsor of 818 studies on the registry; 118 are open to participants now.
Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Perioperative placebo IV infusion besides the standard anesthesia care, including general anesthesia and postoperative patient controlled analgesia.
Drug: placebo
Perioperative intravenous lidocaine infusion besides the standard anesthesia care, including general anesthesia plus and post operative patient controlled analgesia.
Drug: 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
Also known as: Liodocaine
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
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).
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)
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
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
Duration of Hospitalization
Length of hospital stay will be recorded in days.
Time frame: 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.
Time frame: 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.
Time frame: 90 days post operative
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 .
| Milestone | Lidocaine | Placebo |
|---|---|---|
| Started | 58 | 58 |
| Completed | 57 | 58 |
| Not completed | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
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).
| verbal response scores | Lidocaine | Placebo |
|---|---|---|
| Mean Pain Scores | 4.4 ± 0.13 | 5.3 ± 0.13 |
Opioid consumption during the initial 48 postoperative hours was converted to IV morphine sulfate equivalents
| mg IV morphine equivalent | Lidocaine | Placebo |
|---|---|---|
| Opioid Medication Requirement, mg in IV Morphine Equivalent | 55 ± 8 | 74 ± 11 |
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.
| participants | Lidocaine | Placebo |
|---|---|---|
| Number of Participants With Any Major 30-day Post Operative Complications | 2 | 5 |
Postoperative Nausea and Vomiting (PONV)will be noted during day one and day two postoperative.
| participants | Lidocaine | Placebo |
|---|---|---|
| Nausea | 4 | 8 |
| Vomiting | 2 | 1 |
Length of hospital stay will be recorded in days.
| days | Lidocaine | Placebo |
|---|---|---|
| Duration of Hospitalization | 3 (2 to 4) | 3 (2 to 4) |
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.
| units on a scale | Lidocaine | Placebo |
|---|---|---|
| 12-item Short Form Survey (SF-12) Physical Health Composite Score | 38 (31 to 47) | 33 (27 to 42) |
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.
| units on a scale | Lidocaine | Placebo |
|---|---|---|
| 12-item Short Form Survey (SF-12) Physical Health Composite Score | 39 (31 to 49) | 34 (28 to 44) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lidocaine | — | 0/57 (0%) | 0/57 (0%) |
| Placebo | — | 0/58 (0%) | 0/58 (0%) |
| Age, Continuous(years) | Lidocaine | Placebo | Total |
|---|---|---|---|
| Mean | 58 ± 11 | 54 ± 11 | 56 ± 11 |
| Gender(Participants) | Lidocaine | Placebo | Total |
|---|---|---|---|
| Female | 22 | 23 | 45 |
| Male | 35 | 35 | 70 |
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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