The Effect of Perioperative Intravenous Lidocaine Infusion on Opioid Consumption After Lumbar Spine Surgery
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| ClinicalTrials.gov Identifier: NCT03624985 |
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Recruitment Status : Unknown
Verified August 2018 by Tim Dominick, University of Vermont Medical Center.
Recruitment status was: Recruiting
First Posted : August 10, 2018
Last Update Posted : August 10, 2018
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pain, Postoperative Opioid Use | Drug: Intravenous Lidocaine Infusion Drug: Placebo Infusion | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 140 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Randomized, controlled, double-blind study |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | The Effect of Perioperative Intravenous Lidocaine Infusion on Opioid Consumption After Lumbar Spine Surgery |
| Actual Study Start Date : | June 4, 2018 |
| Estimated Primary Completion Date : | June 4, 2020 |
| Estimated Study Completion Date : | June 9, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Intravenous Lidocaine Infusion
Patients will be randomly assigned to receive 1 mg/kg lidocaine bolus and intraoperative infusion of 2 mg/min.
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Drug: Intravenous Lidocaine Infusion
Patients will be randomly assigned to receive 1 mg/kg lidocaine bolus and intraoperative infusion of 2 mg/min.
Other Name: IV Lidocaine Infusion |
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Placebo Comparator: Placebo Infusion
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.
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Drug: Placebo Infusion
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
Other Names:
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- Total morphine equivalent consumed at 24 hours after surgery [ Time Frame: 24 hours postoperatively ]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.
- Total morphine equivalent consumed at 48 hours after surgery [ Time Frame: 48 hours postoperatively ]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.
- Pain score 4 hours post-operation [ Time Frame: 4 hours postoperatively ]
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
- Pain score 10 hours post-operation [ Time Frame: 10 hours postoperatively ]
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
- Pain score 24 hours post-operation [ Time Frame: 24 hours postoperatively ]
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
- Pain score 48 hours post-operation [ Time Frame: 48 hours postoperatively ]
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
- Quality of Recovery Score 36 hours post-operation [ Time Frame: 36 hours postoperatively ]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.
- Quality of Recovery Score 48 hours post-operation [ Time Frame: 48 hours postoperatively ]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.
- Length of Stay [ Time Frame: During hospitalization, approximately 5 days ]Length of stay in the hospital, defined as time between admission and discharge. Unit of measure: Days.
- Incidence of nausea [ Time Frame: During hospitalization, approximately 5 days ]A count of the incidences of treatment of nausea with medication.
- Time to first flatus [ Time Frame: 96 hours postoperatively ]Time of first flatus will be recorded by floor nurses and extracted from the electronic medical record. Unit of measure: Hours.
- Time to first bowel movement [ Time Frame: 96 hours postoperatively ]Time of first bowel movement will be recorded by floor nurses and extracted from the electronic medical record. Unit of measure: Hours.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03624985
| Contact: Alexander Friend, MS | 8028474259 | alexander.friend@uvmhealth.org |
| United States, Vermont | |
| University of Vermont Medical Center | Recruiting |
| Burlington, Vermont, United States, 05401 | |
| Contact: Alexander Friend, MS 802-847-4259 alexander.friend@uvmhealth.org | |
| Principal Investigator: Timothy Dominick, MD | |
| Principal Investigator: David Lunardini, MD | |
| Principal Investigator: | Timothy Dominick, MD | Anesthesiologist | |
| Principal Investigator: | David Lunardini, MD | Orthopedic Surgeon |
Publications:
| Responsible Party: | Tim Dominick, Anesthesiologist, University of Vermont Medical Center |
| ClinicalTrials.gov Identifier: | NCT03624985 |
| Other Study ID Numbers: |
CHRMS 18-0111 |
| First Posted: | August 10, 2018 Key Record Dates |
| Last Update Posted: | August 10, 2018 |
| Last Verified: | August 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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lidocaine lumbar spine surgery postoperative pain opioid reduction |
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Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations Lidocaine Anesthetics, Local Anesthetics Central Nervous System Depressants |
Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |