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

NCT05010148 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 20-32383
• Study Type: interventional
• Target: 278
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Delirium; Postoperative Pain; Spinal Fusion

Keywords

lidocaine; spinal surgery; opioid sparing

Outcome Measures

Primary Outcomes (1)

• Incidence of Postoperative Delirium

  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.

  From 24 hours after start of lidocaine infusion to 3 days after surgery.

Secondary Outcomes (21)

• Severity of Postoperative Delirium

  From 24 hours after start of lidocaine infusion to 3 days after surgery.

• Postoperative Opioid Use

  From 24 hours after start of lidocaine infusion to discharge, up to one week.

• Difference in Postoperative Pain Scores Between Treatment Groups

  From 8 hours after start of lidocaine infusion to discharge, up to one week.

• Difference in Analgesic Satisfaction Scores Between Treatment Groups

  From 24 hours after start of lidocaine infusion to 3 days after surgery.

• Difference in Opioid Related Side Effects Between Treatment Groups: Respiratory Depression-Respiratory Rate

  From 4 hours after start of lidocaine infusion to discharge, up to one week.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Intervention-Intravenous Lidocaine Infusion

EXPERIMENTAL

Will be administered intravenous lidocaine at 1.33mg/kg/hr (adjusted body weight) for 48 hours following major spinal surgery.

Drug: Lidocaine IV

Interventions

Lidocaine IV DRUG

Intravenous lidocaine will be given at 1.33mg/kg/hr (adjusted body weight) for 48 hours following major spinal surgery

Also known as: Lidocaine, xylocaine

Intervention-Intravenous Lidocaine Infusion

Placebo DRUG

D5 water given at an equivalent ml/hr as intravenous lidocaine (treatment arm) for 48 hours following major spinal surgery

Also known as: Placebo, D5 water

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Surgical:
• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

Related Publications (1)

• Buren MA, Theologis A, Zuraek A, Behrends M, Clark AJ, Leung JM. Lidocaine Infusion for the Management of Postoperative Pain and Delirium (LIMPP): protocol for a randomised control trial. BMJ Open. 2022 Jun 6;12(6):e059416. doi: 10.1136/bmjopen-2021-059416.

  PMID: 35667730 DERIVED

MeSH Terms

Conditions

Emergence Delirium; Pain, Postoperative

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Pain

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Marc A Buren, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc A Buren, MD

CONTACT

415-476-8369; marc.buren@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: August 18, 2021
• Study Start: September 17, 2021
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Within 12 months following publication.
• Access Criteria: To other researchers upon request.

Locations

US (1)