Lidocaine IV for Postoperative Pain

University of California, San Francisco, San Francisco, CA
Targeting 3 different conditionsLidocaine IV +1 morePhase 3RecruitingLed by Marc A Buren, MDResearch Sponsored by University of California, San Francisco

Study 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.

Eligible Conditions
  • Postoperative Pain
  • Spinal Fusion
  • Delirium

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You have scheduled spinal fusion surgery that is not related to this clinical trial.


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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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.
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved

Find a site

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,414 Previous Clinical Trials
12,301,450 Total Patients Enrolled
6 Trials studying Postoperative Pain
3,145 Patients Enrolled for Postoperative Pain
Marc A Buren, MDPrincipal Investigator
University 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 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
~79 spots leftby Sep 2024