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IV Lidocaine for Postoperative Pain and Delirium (LIMPP Trial)

Phase 3

Recruiting

Led By Marc A Buren, MD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Elective spinal fusion surgery

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 3 months.

Awards & highlights

LIMPP Trial Summary

This trial is testing whether using lidocaine to control postoperative pain may decrease the risk of postoperative delirium and other opioid-related side effects, following major reconstructive spinal surgery.

Who is the study for?

This trial is for adults who are fluent in English and scheduled for elective spinal fusion surgery with a stay of at least 3 days. It's not suitable for those allergic to lidocaine, with severe liver or kidney issues, acute porphyria, high preoperative opioid use, severe cognitive impairment, or significant heart disease.Check my eligibility

What is being tested?

The study tests if intravenous Lidocaine after spinal surgery can prevent delirium and reduce pain compared to a placebo. Participants will receive either Lidocaine IV or a placebo infusion post-surgery to assess the effectiveness in managing pain and preventing delirium.See study design

What are the potential side effects?

Lidocaine may cause side effects such as dizziness, sleepiness, numbness around the mouth, tingling sensations, visual disturbances or confusion. Severe reactions are rare but could include seizures or serious heart-related events.

LIMPP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for elective spinal fusion surgery.

LIMPP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 3 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 3 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 3 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Postoperative Delirium

Secondary outcome measures

Cognitive Status

Difference in Ability to Participate in Physical Therapy Between Treatment Groups

Difference in Analgesic Satisfaction Scores Between Treatment Groups

+18 more

LIMPP Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Intervention-Intravenous Lidocaine InfusionExperimental Treatment1 Intervention

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

Group II: PlaceboPlacebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lidocaine IV

2020

Completed Phase 4

~450

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor

2,505 Previous Clinical Trials

15,237,277 Total Patients Enrolled

6 Trials studying Postoperative Pain

3,145 Patients Enrolled for Postoperative Pain

Marc A Buren, MDPrincipal InvestigatorUniversity of California, San Francisco

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT05010148 — Phase 3

Postoperative Pain Research Study Groups: Placebo, Intervention-Intravenous Lidocaine Infusion

Postoperative Pain Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05010148 — Phase 3

Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT05010148 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what reasons might a doctor prescribe Lidocaine IV?

"Lidocaine IV is often used to manage cervical syndrome but it has also been effective in treating other conditions like minor burns, osteoporosis, and transplantation."

Answered by AI

Are researchers actively seeking participants for this trial?

"That is correct, the trial is recruiting patients at the moment. The original posting date was September 17th, 2021 and the most recent update was on March 17th, 2022. They are looking for 278 individuals in total from 1 centre."

Answered by AI

What is the FDA's position on Lidocaine given intravenously?

"Lidocaine IV received a score of 3 due to there being supportive clinical data from previous Phase 3 trials."

Answered by AI

How many patients are receiving care through this program?

"That is correct, the posted information on clinicaltrials.gov does show that this trial is currently looking for participants. The trial was first posted on September 17th, 2021 and was last updated on March 17th, 2022. They are trying to recruit 278 patients from 1 location."

Answered by AI

What is the efficacy of Lidocaine IV in other medical research?

"Right now, there are a total of 135 different active clinical studies investigating the use of Lidocaine IV. This includes 34 Phase 3 trials. The majority of these investigations are taking place in Calgary, Alberta. However, there are 1083 medical centres conducting research on Lidocaine IV across the globe."

Answered by AI

Recent research and studies

BMJ OpenJournal

Lidocaine Infusion for the Management of Postoperative Pain and Delirium (LIMPP): Protocol for a Randomised Control Trial

Buren, Marc Alan, Alekos Theologis, Ariadne Zuraek, Matthias Behrends, Aaron J Clark, and Jacqueline M Leung. 2022. “Lidocaine Infusion for the Management of Postoperative Pain and Delirium (LIMPP): Protocol for a Randomised Control Trial”. BMJ Open. BMJ. doi:10.1136/bmjopen-2021-059416.

clinicaltrials.govStudy

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

2021. "A Clinical Trial of Intravenous Lidocaine After Spinal Surgery to Prevent Delirium and Reduce Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05010148.

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