A Phase 4 interventional study of Intravenous Lidocaine Infusion and Placebo Infusion in Pain, Postoperative and Opioid Use, sponsored by University of Vermont Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-01-31.
Sponsored by University of Vermont Medical Center · Phase 4, Interventional, and Treatment
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.
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.
5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.
This study's enrollment of 61 is below the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.
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Exclusion Criteria:
Patients will be randomly assigned to receive 1 mg/kg lidocaine bolus and intraoperative infusion of 2 mg/min.
Drug: Intravenous Lidocaine 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.
Drug: Placebo Infusion
Patients will be randomly assigned to receive 1 mg/kg lidocaine bolus and intraoperative infusion of 2 mg/min.
Also known as: IV Lidocaine 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
Also known as: Placebo, Control, Comparator
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.
Time frame: 24 hours postoperatively
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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 48 hours postoperatively
Length of Stay
Length of stay in the hospital, defined as time between admission and discharge. Unit of measure: Days.
Time frame: During hospitalization, approximately 5 days
Incidence of nausea
A count of the incidences of treatment of nausea with medication.
Time frame: 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.
Time frame: 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.
Time frame: 96 hours postoperatively
Plan to share: No
This study is terminated, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lidocaine
University of Vermont Medical Center