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

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

Trial Summary

What is the purpose of this trial?

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.

Research Team

Marc A Buren, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+