The Effect of Perioperative Intravenous Lidocaine Infusion on Opioid Consumption After Lumbar Spine Surgery

Study Overview
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Brief Summary
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The purpose of this study is to determine whether an infusion of lidocaine during surgery can reduce the need for postoperative opioid pain medication use in patients undergoing lumbar spine surgery. Participants will be recruited by spine surgeons from their pool of patients who are presenting for surgery at University of Vermont Medical Center. If they agree to participate, patients will be assigned at random to receive either an infusion of lidocaine during surgery, or an infusion of saline with 5% dextrose. Subjects will also be asked to complete a 15-item questionnaire that asks about health, quality of life, and level of pain, at three timepoints. Patients will also be asked to rate their level of pain at multiple timepoints after surgery, and we will collect the additionally data from patients' medical records.

Detailed Description
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Lidocaine has analgesic and anti-inflammatory effects. It has been shown to reduce early postoperative pain and nausea. Additionally, lidocaine has been shown to have positive effects in the recovery of bowel function, with a reduction in time to first flatus, first bowel sounds, first bowel movement, and is associated with a reduction of ileus. Because of these facts, lidocaine infusion has become part of enhanced recovery pathways after bowel surgery at our institution and others. There are few trials examining the use of lidocaine for orthopedic procedures and many of these studies have contradictory adults. An article by Martin et al. found no benefit in pain or recovery after total hip arthroplasty. By contrast, Farag and colleagues found that lidocaine significantly improves postoperative pain after major spine surgery. Additionally, quality of life scores at one and three months after surgery were significantly higher in the lidocaine group. When our Spine Surgery Analgesic Protocol for major spine surgery at University of Vermont Medical Center was revised in 2015, a lidocaine infusion was added to the protocol. Studies for lidocaine use in minor lumbar surgery are scant. In one study of 50 patients in Korea, patient pain scores and fentanyl consumption were significantly lower in the lidocaine infusion group (1.5 mg/kg bolus plus 2 mg/kg/hr infusion) at 2, 4, 8, 12 and 24 hours after surgery. Of note, the Cleveland Clinic Outcomes group is currently enrolling 440 patients in a study in which half will receive lidocaine and ketamine infusions. A reduction in opioid use may lead to the potential reduction of opioid-related side effects, such as nausea, constipation, and hyperalgesia, as well as more serious consequences such as respiratory depression and abuse. There is also the possibility of a length of stay reduction which has potential financial benefits. This is a randomized, controlled, double-blind study involving patients undergoing one- or two-level posterior lumbar instrumented spinal fusion with or without decompression. The University of Vermont Medical Center operating rooms will be utilized for this investigation. For the study group, we plan to prospectively recruit 140 patients 18-75 years of age. Recruitment will be done by the participating orthopedists and neurosurgeons, from their own patients. After an informed consent discussion, patients will be randomly assigned to receive 1 mg/kg lidocaine bolus and intraoperative infusion of 2 mg/min (intervention arm) or no lidocaine (control arm). All patients will receive adequate pain control medication according to their needs. Subjects will complete the 15-question Quality of Recovery assessment at baseline and at 36 and 60 hours after surgery. Using the electronic medical system, the following information with extracted: Total morphine equivalent used in house at 36 hours, total morphine equivalents used at 60 hours, visual analog scale pain scores at 4, 8, 12, 24, 36, and 60 hours, length of stay, incidence of nausea requiring medication, time to first flatus, and time to first bowel movement. Subjects will receive a patient-controlled analgesia pump for the first 36 hours after surgery. Randomization will be performed by the University of Vermont Medical Center Investigational Pharmacy Drug Service (IDS). IDS will generate a table of random numbers and assign those numbers in a 1:1 ratio of active drug to placebo, in blocks of 4. Following informed consent, a member of the study team will notify IDS, which will prepare syringes for the bolus dose and a bag for the infusion, both containing either active drug or placebo. The syringes and bag will be labeled with the subject's name, medical record number, and randomization number.

Official Title
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The Effect of Perioperative Intravenous Lidocaine Infusion on Opioid Consumption After Lumbar Spine Surgery

Conditions
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Pain, Postoperative, Opioid Use

Intervention / Treatment
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* Drug: Intravenous Lidocaine Infusion
* Drug: Placebo Infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient undergoing one- or two-level posterior lumbar fusion with or without decompression at University of Vermont Medical Center 18-75 years of age Signed consent form Exclusion Criteria: Allergy to lidocaine Contraindication to lidocaine, such as substantial hepatic impairment (alanine aminotransferase or aspartate transaminase more than twice normal), renal impairment (serum creatinine >2 mg/dl) Seizures or a history of seizure disorder Congestive heart failure Arrythmias Chronic opioid use >45 mg morphine equivalent per day Trauma patients Inter-body fusions Severe psychiatric comorbidities Planned epidural anesthesia or analgesia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, controlled, double-blind study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intravenous Lidocaine Infusion<br>Patients will be randomly assigned to receive 1 mg/kg lidocaine bolus and intraoperative infusion of 2 mg/min. | Drug: Intravenous Lidocaine Infusion<br>* Patients will be randomly assigned to receive 1 mg/kg lidocaine bolus and intraoperative infusion of 2 mg/min.<br>* Other names: IV Lidocaine Infusion;|
| Placebo Comparator: Placebo Infusion<br>Patients will be randomly assigned to receive a 1mg/kg bolus of water with 5% dextrose and an intraoperative infusion of 2mg/min. of water with 5% dextrose. | Drug: Placebo Infusion<br>* Patients will be randomly assigned to receive a 1mg/kg bolus of water with 5% dextrose and an intraoperative infusion of 2mg/min. of water with 5% dextrose<br>* Other names: Comparator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total morphine equivalent consumed at 24 hours after surgery | Subjects will receive a patient-controlled analgesia pump for the first 24 hours after surgery. Total morphine equivalent will be calculated according to the Centers for Disease Control and Prevention conversion factor for calculating morphine milligram equivalents. | 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total morphine equivalent consumed at 48 hours after surgery | Electronic medical records will be reviewed to total opioids received after the patient-controlled analgesia pump is discontinued. Total morphine equivalent will be calculated according to the Centers for Disease Control and Prevention conversion factor for calculating morphine milligram equivalents. | 48 hours postoperatively | 
| Pain score 4 hours post-operation | Visual analog scale pain scores 4 hours after the end of the operation. The visual analog scale is presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of no pain at all and worst pain imaginable. The patient marks a point on the line that matches the amount of pain they feel. 0 = no pain 100 = worst pain imaginable | 4 hours postoperatively | 
| Pain score 10 hours post-operation | Visual analog scale pain scores 10 hours after the end of the operation. The visual analog scale is presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of no pain at all and worst pain imaginable. The patient marks a point on the line that matches the amount of pain they feel. 0 = no pain 100 = worst pain imaginable | 10 hours postoperatively | 
| Pain score 24 hours post-operation | Visual analog scale pain scores 24 hours after the end of the operation. The visual analog scale is presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of no pain at all and worst pain imaginable. The patient marks a point on the line that matches the amount of pain they feel. 0 = no pain 100 = worst pain imaginable | 24 hours postoperatively | 
| Pain score 48 hours post-operation | Visual analog scale pain scores 48 hours after the end of the operation. The visual analog scale is presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of no pain at all and worst pain imaginable. The patient marks a point on the line that matches the amount of pain they feel. 0 = no pain 100 = worst pain imaginable | 48 hours postoperatively | 
| Quality of Recovery Score 36 hours post-operation | Subjects will complete the 15-question Quality of Recovery 36 hours after the end of surgery. Scores will be compared to the baseline taken in the pre-operative hold area. | 36 hours postoperatively | 
| Quality of Recovery Score 48 hours post-operation | Subjects will complete the 15-question Quality of Recovery 48 hours after the end of surgery. Scores will be compared to the baseline taken in the pre-operative hold area. | 48 hours postoperatively | 
| Length of Stay | Length of stay in the hospital, defined as time between admission and discharge. Unit of measure: Days. | During hospitalization, approximately 5 days | 
| Incidence of nausea | A count of the incidences of treatment of nausea with medication. | During hospitalization, approximately 5 days | 
| Time to first flatus | Time of first flatus will be recorded by floor nurses and extracted from the electronic medical record. Unit of measure: Hours. | 96 hours postoperatively | 
| Time to first bowel movement | Time of first bowel movement will be recorded by floor nurses and extracted from the electronic medical record. Unit of measure: Hours. | 96 hours postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lidocaine, opioid reduction, lumbar spine surgery, postoperative pain