Pain, Postoperative Clinical Trial
Official title:
The Effect of Perioperative Intravenous Lidocaine Infusion on Opioid Consumption After Lumbar Spine Surgery
Verified date | January 2023 |
Source | University of Vermont Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 61 |
Est. completion date | October 14, 2019 |
Est. primary completion date | October 14, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Vermont Medical Center | Burlington | Vermont |
Lead Sponsor | Collaborator |
---|---|
University of Vermont Medical Center |
United States,
Farag E, Ghobrial M, Sessler DI, Dalton JE, Liu J, Lee JH, Zaky S, Benzel E, Bingaman W, Kurz A. Effect of perioperative intravenous lidocaine administration on pain, opioid consumption, and quality of life after complex spine surgery. Anesthesiology. 2013 Oct;119(4):932-40. doi: 10.1097/ALN.0b013e318297d4a5. — View Citation
Hollmann MW, Durieux ME. Local anesthetics and the inflammatory response: a new therapeutic indication? Anesthesiology. 2000 Sep;93(3):858-75. doi: 10.1097/00000542-200009000-00038. No abstract available. — View Citation
Kim KT, Cho DC, Sung JK, Kim YB, Kang H, Song KS, Choi GJ. Intraoperative systemic infusion of lidocaine reduces postoperative pain after lumbar surgery: a double-blinded, randomized, placebo-controlled clinical trial. Spine J. 2014 Aug 1;14(8):1559-66. doi: 10.1016/j.spinee.2013.09.031. Epub 2013 Nov 8. — View Citation
Marret E, Rolin M, Beaussier M, Bonnet F. Meta-analysis of intravenous lidocaine and postoperative recovery after abdominal surgery. Br J Surg. 2008 Nov;95(11):1331-8. doi: 10.1002/bjs.6375. — View Citation
Martin F, Cherif K, Gentili ME, Enel D, Abe E, Alvarez JC, Mazoit JX, Chauvin M, Bouhassira D, Fletcher D. Lack of impact of intravenous lidocaine on analgesia, functional recovery, and nociceptive pain threshold after total hip arthroplasty. Anesthesiology. 2008 Jul;109(1):118-23. doi: 10.1097/ALN.0b013e31817b5a9b. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Incidence of nausea | A count of the incidences of treatment of nausea with medication. | During hospitalization, approximately 5 days | |
Secondary | 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 | |
Secondary | 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 |
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