Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Clinical Trial of Intravenous Lidocaine After Spinal Surgery to Prevent Delirium and Reduce Pain (LIMPP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05010148
Recruitment Status : Recruiting
First Posted : August 18, 2021
Last Update Posted : September 21, 2021
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
Postoperative delirium is one of the most frequent adverse events following elective non-cardiac surgery and is associated with cognitive impairment at discharge, as well as in-hospital and long-term mortality, however, despite being a well-recognized problem there is a dearth of effective interventions for prevention and management. A modifiable risk factor associated with postoperative delirium is poor postoperative pain control, and by improving the pain regimen the investigators may be able to decrease the incidence and/or severity of postoperative delirium. In this study, the investigators seek to study whether a postoperative intravenous infusion of lidocaine, known to improve pain control in other contexts, can decrease the risk of postoperative delirium and other opioid-related side effects, following major reconstructive spinal surgery.

Condition or disease Intervention/treatment Phase
Postoperative Delirium Postoperative Pain Spinal Fusion Drug: Lidocaine IV Drug: Placebo Phase 3

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Continuous Post-operative Lidocaine Infusion Following Major Reconstructive Spine Surgery in the Elderly to Minimize Delirium and Opiate Use: A Randomized Control Trial
Actual Study Start Date : September 17, 2021
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
Placebo Comparator: Placebo
Patients will be administered D5 water intravenously at the same infusion rate (ml/hr) as the intervention group for 48 hours after major spinal surgery.
Drug: Placebo
D5 water given at an equivalent ml/hr as intravenous lidocaine (treatment arm) for 48 hours following major spinal surgery
Other Name: Placebo, D5 water

Experimental: Intervention-Intravenous Lidocaine Infusion
Will be administered intravenous lidocaine at 1.33mg/kg/hr (adjusted body weight) for 48 hours following major spinal surgery.
Drug: Lidocaine IV
Intravenous lidocaine will be given at 1.33mg/kg/hr (adjusted body weight) for 48 hours following major spinal surgery
Other Name: Lidocaine, xylocaine




Primary Outcome Measures :
  1. Incidence of Postoperative Delirium [ Time Frame: From 24 hours after start of lidocaine infusion to 3 days after surgery. ]
    Confusion Assessment Method (CAM) will be performed once daily using a structured interview to assess for delirium incidence. Delirium cases will be validated by a second investigator. Investigators will collect preoperative and surgery related variables that may be associated with delirium.


Secondary Outcome Measures :
  1. Severity of Postoperative Delirium [ Time Frame: From 24 hours after start of lidocaine infusion to 3 days after surgery. ]
    To rate delirium severity, the Memorial Delirium Assessment Scale (MDAS) will be used.

  2. Postoperative Opioid Use [ Time Frame: From 24 hours after start of lidocaine infusion to discharge, up to one week. ]
    Postoperative opioids will be measured and abstracted from the electronic medical record. The investigators will convert all opioids to oral morphine equivalents.

  3. Difference in Postoperative Pain Scores Between Treatment Groups [ Time Frame: From 8 hours after start of lidocaine infusion to discharge, up to one week. ]
    Pain will be measured every 8 hours using the 11-point visual analog scale (0=no pain and 10=the worst pain possible) both at rest and with movement preoperatively and daily postoperatively during the hospital admission. In addition, the site and treatment of pain, and the maximal level of pain experienced postoperatively will be measured. Patients will be asked daily about the quality of their analgesic regimen and will be asked at their first postoperative follow up appointment with their surgeon.

  4. Difference in Opioid Related Side Effects Between Treatment Groups: Respiratory Depression-Respiratory Rate [ Time Frame: From 4 hours after start of lidocaine infusion to discharge, up to one week. ]
    Respiratory rate will be assessed by reviewing the electronic medical record, with less than 8 breaths per minute defined as respiratory depression.

  5. Difference in Opioid Related Side Effects Between Treatment Groups: Respiratory Depression-Saturated Pulse Oximetry [ Time Frame: From 4 hours after start of lidocaine infusion to discharge, up to one week. ]
    Saturate Pulse Oximetry will be assessed by reviewing the electronic medical record, with a saturation less than 95% defined as respiratory depression.

  6. Difference in Opioid Related Side Effects Between Treatment Groups: Respiratory Depression-Naloxone Administration [ Time Frame: From 4 hours after start of lidocaine infusion to discharge, up to one week. ]
    Naloxone administration will be assessed by reviewing the electronic medical record, and naloxone administration will count as respiratory depression.

  7. Difference in Opioid Related Side Effects Between Treatment Groups: Sedation [ Time Frame: From 4 hours after start of lidocaine infusion to discharge, up to one week. ]
    Sedation will be assess by the Pasero opioid-induced sedation scale.

  8. Difference in Opioid Related Side Effects Between Treatment Groups: Nausea, Vomiting, Constipation-Investigator Assessments [ Time Frame: From 4 hours after start of lidocaine infusion to discharge, up to one week. ]
    Investigators will conduct daily assessments for symptoms of nausea, vomiting, and constipation.

  9. Difference in Opioid Related Side Effects Between Treatment Groups: Nausea, Vomiting, Constipation-Anti-Emetic Administration [ Time Frame: From 4 hours after start of lidocaine infusion to discharge, up to one week. ]
    Administration of anti-emetics will be assessed by reviewing the electronic medical record.

  10. Difference in Opioid Related Side Effects Between Treatment Groups: Pruritus-Investigator Assessment [ Time Frame: From 4 hours after start of lidocaine infusion to discharge, up to one week. ]
    Investigators will conduct daily assessments for symptoms of pruritus.

  11. Difference in Functional Outcome Between Treatment Groups Using Short Form 36 (SF-36) [ Time Frame: Baseline and 3 months. ]
    Functional recovery from spine surgery will be measured by comparing preoperative and postoperative scores on a variety of questionnaires including the Short-Form 36.

  12. Difference in Functional Outcome Between Treatment Groups Using Oswestry Disability Index (ODI) [ Time Frame: Baseline and 3 months. ]
    Functional recovery from spine surgery will be measured by comparing preoperative and postoperative scores on a variety of questionnaires including the Oswestry Disability Index.

  13. Difference in Time to Discharge Between Treatment Groups [ Time Frame: End of hospitalization, at time of discharge, approximately 1 week. ]
    Functional recovery will be assessed in terms of time to discharge from the hospital.

  14. Difference in Ability to Participate in Physical Therapy Between Treatment Groups [ Time Frame: From 24 hours after start of lidocaine infusion to 3 days after surgery. ]
    Functional recovery will be assessed in terms of the patient's ability to participate with postoperative physical therapy monitored by review of daily physical therapy notes.

  15. Difference in lidocaine related Adverse Events between treatment groups [ Time Frame: From 4 hours after the start of the lidocaine infusion up to 72 hours. ]
    The difference in lidocaine treatment related adverse events will be assessed with a screening questionnaire of lidocaine toxicity associated symptoms and compared between treatment groups.



Information from the National Library of Medicine

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.


Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Elective spinal fusion surgery
  • Estimated length of stay ≥3 days
  • Fluent in English

Exclusion Criteria:

Surgical:

  • 2-stage spine surgery i.e. anterior-posterior on separate days*
  • Cervical spine surgery
  • Non-spine surgeries

Other:

  • Allergy or intolerance of lidocaine
  • Significant heart disease (2nd or 3rd heart block without a pacemaker, Left ventricular ejection fraction (LVEF) <30%, significant arrhythmia [Adams-strokes, Wolff-Parkinson-white syndrome], concurrent treatment with a class 1 antiarrhythmic or amiodarone)
  • Significant hepatic or renal dysfunction
  • History of uncontrolled seizures
  • Acute porphyria
  • Preoperative usage of long-acting opioids (methadone, buprenorphine, fentanyl patch, ms-contin, oxycontin) or preoperative opioid usage greater than or equal to the equivalent of 60 mg of oral morphine equivalents.
  • Severe cognitive impairment (reported by proxy or a score of >5 on the Short Portable Mental Status Questionnaire (SPMSQ))
  • Self-, or proxy-reported physical impairment preventing the subject from consenting or answering questions
  • Evidence of preoperative delirium
  • Participated in Clinical Trial of Gabapentin to Decrease Postoperative Delirium and Pain (GIPP) or Postoperative Cognition in Older Adult Surgical Patients (PCD) study previously
  • Participating in any other clinical trial

Information from the National Library of Medicine

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): NCT05010148


Contacts
Layout table for location contacts
Contact: Marc A Buren, MD 415-476-8369 marc.buren@ucsf.edu

Locations
Layout table for location information
United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Marc Buren, MD    415-514-3781    marc.buren@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Investigators
Layout table for investigator information
Principal Investigator: Marc A Buren, MD University of California, San Francisco
  Study Documents (Full-Text)

Documents provided by University of California, San Francisco:
Informed Consent Form  [PDF] March 31, 2021

Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05010148    
Other Study ID Numbers: 20-32383
First Posted: August 18, 2021    Key Record Dates
Last Update Posted: September 21, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected individual participant data (IPD).
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Within 12 months following publication.
Access Criteria: To other researchers upon request.

Layout table for additional information
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.: Yes
Keywords provided by University of California, San Francisco:
lidocaine
spinal surgery
opioid sparing
Additional relevant MeSH terms:
Layout table for MeSH terms
Delirium
Neurologic Manifestations
Confusion
Neurobehavioral Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
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