IV Lidocaine for Postoperative Pain and Delirium

(LIMPP Trial)

Overseen By Marc A Buren, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of California, San Francisco

Must not be taking: Long-acting opioids, Amiodarone

Disqualifiers: Heart disease, Hepatic dysfunction, Seizures, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 1 week

278 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether an IV infusion of lidocaine, a common pain reliever, can reduce the risk of delirium (a state of confusion) after major spinal surgeries. Delirium often occurs after surgery and can lead to serious long-term problems, so researchers aim to determine if better pain management can help. They compare lidocaine's effects to a placebo to assess its effectiveness. Individuals planning elective spinal fusion surgery with an expected hospital stay of at least three days might be suitable candidates for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it does exclude those using certain long-acting opioids or high doses of opioids before surgery. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that IV (intravenous) lidocaine often helps manage pain after surgery. This treatment is generally safe when administered correctly but can be dangerous if not. Earlier studies have shown that lidocaine can improve pain control and might reduce the risk of confusion after surgery. One study found that lidocaine lowered the chances of developing short-term thinking and memory problems post-surgery. While lidocaine is used for other conditions and has shown positive effects, medical supervision is crucial to avoid serious side effects. This trial aims to provide more information on its safety and effectiveness in preventing post-surgery problems. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for postoperative pain and delirium?

Unlike the standard of care for postoperative pain and delirium, which typically involves opioids and other pain medications, intravenous lidocaine offers a novel approach. Researchers are excited about this treatment because lidocaine is administered systemically through an IV, potentially providing pain relief without the side effects associated with opioids. Additionally, lidocaine's action as a local anesthetic may help reduce inflammation and nerve-related pain, addressing both pain and delirium after major spinal surgery. This dual action makes it a promising alternative to current treatment options, offering the possibility of improved recovery outcomes for patients.

What evidence suggests that intravenous lidocaine might be an effective treatment for postoperative delirium?

Research has shown that intravenous lidocaine, which participants in this trial may receive, can help manage pain after surgery. One study with older patients who had hip fractures found that lidocaine reduced postoperative delirium, a type of confusion and disorientation that can occur after surgery. Another study found that lidocaine not only eased pain but also helped patients recover faster. Additionally, evidence suggests that lidocaine can lower the risk of postoperative delirium in patients undergoing major spinal surgery. These findings highlight lidocaine's potential to improve recovery and reduce complications after surgery. Participants in this trial may also receive a placebo, administered as D5 water intravenously at the same infusion rate as the lidocaine group. ^{1 2 3 5 6}

Who Is on the Research Team?

Marc A Buren, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am scheduled for elective spinal fusion surgery.

Estimated length of stay ≥3 days

Fluent in English

Exclusion Criteria

Participating in any other clinical trial

I do not have severe heart issues like very low heart pump function or dangerous irregular heartbeats.

Severe cognitive impairment (reported by proxy or a score of >5 on the Short Portable Mental Status Questionnaire (SPMSQ))

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either intravenous lidocaine or placebo infusion for 48 hours following major spinal surgery

1 week

Daily assessments during hospitalization

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of postoperative delirium and functional recovery

3 months

Follow-up assessments at 3 months

Postoperative Monitoring

Daily assessments for symptoms of pruritus, nausea, vomiting, constipation, and sedation

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Lidocaine IV
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention-Intravenous Lidocaine Infusion Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 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.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10730424/

Effect of Intraoperative Intravenous Lidocaine on ... This study was performed to evaluate the effects of intraoperative intravenous lidocaine on postoperative delirium in elderly patients with hip fracture.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9114851/

Efficacy of systemic lidocaine in postoperative delirium in ... Systemic lidocaine may reduce pain intensity and accelerate postoperative recovery. However, the efficacy of systemic lidocaine in cognitive ...

3. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT05010148

A Clinical Trial of Intravenous Lidocaine After Spinal Surgery ... A postoperative intravenous infusion of lidocaine, known to improve pain control in other contexts, can decrease the risk of postoperative delirium.

4. associationofanaesthetists-publications.onlinelibrary.wiley.com associationofanaesthetists-publications.onlinelibrary.wiley.com/doi/10.1111/anae.15270

The use of intravenous lidocaine for postoperative pain and ... Intravenous lidocaine is used widely for its effect on postoperative pain and recovery but it can be, and has been, fatal when used inappropriately and ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05072314

Long-term Outcomes of Lidocaine Infusions for Post- ... The trial's purpose is to evaluate the effectiveness of lidocaine infusions commenced during surgery and extending up to 24 hours postoperatively.

6. bmcanesthesiol.biomedcentral.com bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-023-02202-0

The effect of intravenous lidocaine on postoperative cognitive ... Outcomes. We found that lidocaine could attenuate the overall incidence of POCD, especially in the short term. There were no differences between ...