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

NCT03624985 | Terminated Phase 4 FDA Drug

• 1 other identifier: CHRMS 18-0111
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Postoperative; Opioid Use

Keywords

lidocaine; lumbar spine surgery; postoperative pain; opioid reduction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Total morphine equivalent consumed at 48 hours after surgery

  48 hours postoperatively

• Pain score 4 hours post-operation

  4 hours postoperatively

• Pain score 10 hours post-operation

  10 hours postoperatively

• Pain score 24 hours post-operation

  24 hours postoperatively

• Pain score 48 hours post-operation

  48 hours postoperatively

Study Arms (2)

Intravenous Lidocaine Infusion

EXPERIMENTAL

Patients will be randomly assigned to receive 1 mg/kg lidocaine bolus and intraoperative infusion of 2 mg/min.

Drug: Intravenous Lidocaine Infusion

Placebo Infusion

PLACEBO COMPARATOR

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

Interventions

Intravenous Lidocaine Infusion DRUG

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

Intravenous Lidocaine Infusion

Placebo Infusion DRUG

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

Placebo Infusion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient undergoing one- or two-level posterior lumbar fusion with or without decompression at University of Vermont Medical Center
• years of age
• Signed consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Vermont Medical Center: lead

Study Sites (1)

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

Related Publications (5)

• 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.

  PMID: 10969322 BACKGROUND

• 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.

  PMID: 18844267 BACKGROUND

• 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.

  PMID: 18580181 BACKGROUND

• 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.

  PMID: 23681143 BACKGROUND

• 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.

  PMID: 24216403 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Timothy Dominick, MD

  Anesthesiologist

  PRINCIPAL INVESTIGATOR

• David Lunardini, MD

  Orthopedic Surgeon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Model Details: Randomized, controlled, double-blind study

Study Record Dates

• First Submitted: June 13, 2018
• First Posted: August 10, 2018
• Study Start: June 4, 2018
• Primary Completion: October 14, 2019
• Study Completion: October 14, 2019
• Last Updated: January 31, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)