Local/MAC Anesthesia for Lumbar Spinal Stenosis

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Todd Alamin, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: Stanford University

Must not be taking: Morphine

Disqualifiers: Nerve retraction, Previous fusion, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Explore efficacy, complications, and other factors associated with anaesthetic choice- To evaluate the efficacy of local + MAC as an alternative anesthetic to general anesthesia and to analyze patients' outcomes and experiences.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are taking more than 100mg of morphine daily, you may not be eligible to participate.

What data supports the effectiveness of the drug for reducing pain during injection?

Research shows that adding lidocaine to propofol can significantly reduce the pain experienced during its injection, making the process more comfortable for patients. ^{1 2 3 4 5}

Is the combination of lidocaine and propofol safe for use in humans?

Research shows that adding lidocaine to propofol can reduce the pain experienced during injection, which is a common side effect. This suggests that the combination is generally safe for use in humans, as it helps manage discomfort without introducing significant new risks. ^{3 4 6 7 8}

How is the drug used in the trial for lumbar spinal stenosis different from other treatments?

The drug used in the trial combines lidocaine and propofol, which is unique because lidocaine helps reduce the pain associated with propofol injections. This combination is not typically used for lumbar spinal stenosis, making it a novel approach for managing pain during procedures. ^{1 3 4 5 9}

Research Team

Todd Alamin, MD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for individuals aged 40-95 with lumbar spinal stenosis needing decompression over 1-3 segments and who are suitable for general anesthesia. It excludes those unable to follow up, on high daily morphine doses, previous back fusion surgery, or allergies to eggs, soy, or propofol components.

Inclusion Criteria

Patients appropriate for general anesthesia

I have lumbar stenosis needing surgery on 1-3 spine segments.

I am between 40 and 95 years old.

Exclusion Criteria

I take 100mg or more of pain medication daily.

Patients with a known hypersensitivity to propofol or any of DIPRIVAN Injectable Emulsion components

Patients with allergies to eggs, egg products, soybeans, or soy products

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo lumbar decompression surgery with either general anesthesia or local anesthetic with MAC

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Regular follow-up visits

Treatment Details

Interventions

• Lidocaine Hydrochloride, Injectable (Local Anesthetic)
• Propofol Injection (General Anesthetic)

Trial Overview The study compares the effectiveness of local plus MAC (Monitored Anesthesia Care) anesthesia versus general anesthesia in patients undergoing lumbar decompression surgery. It aims to assess patient outcomes and experiences with these anesthetic methods.

Participant Groups

Group I: Monitored Anesthetic Care (MAC)/Local Active Control 1 Intervention

Patients under this group wil be undergoing limbar decompression surgery with Monitored Anesthetic care, (MAC)/Local. Local + MAC: Local anesthetic (lidocaine) injected into the site of the incision/dissection with additional IV medication (Propofol) to achieve a state in which the patient is generally aware, but relaxed.

Group II: General anesthesia Active Control 1 Intervention

Patients under this group will be undergoing lumbar decompression surgery with general anesthesia: General Anesthesia: Medically induced unconsciousness that suppresses reflexes and requires intubation (a tube inserted through the mouth and into the airway) to assist in breathing.

Lidocaine Hydrochloride, Injectable is already approved in Canada, Japan, China, Switzerland for the following indications:

Approved in Canada as Lidocaine for:

• Local anesthesia
• Regional anesthesia
• Postherpetic neuralgia
• Anal itching
• Burns
• Gastrointestinal surgery
• Neuropathic pain

Approved in Japan as Lidocaine for:

• Local anesthesia
• Regional anesthesia
• Postherpetic neuralgia
• Anal itching
• Burns
• Gastrointestinal surgery
• Neuropathic pain

Approved in China as Lidocaine for:

• Local anesthesia
• Regional anesthesia
• Postherpetic neuralgia
• Anal itching
• Burns
• Gastrointestinal surgery
• Neuropathic pain

Approved in Switzerland as Lidocaine for:

• Local anesthesia
• Regional anesthesia
• Postherpetic neuralgia
• Anal itching
• Burns
• Gastrointestinal surgery
• Neuropathic pain

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Dr. Richard A. Miller

Stanford University

Chief Executive Officer since 2023

Stanford University, MD

Dr. Robert Schott

Stanford University

Chief Medical Officer since 2021

University of Michigan, MD

Findings from Research

In a study of 120 patients undergoing elective plastic surgery, the combination of lidocaine and flurbiprofen significantly reduced pain during propofol injection compared to placebo, with only 3% of patients reporting pain.

No complications were observed at the injection sites within 24 hours, indicating that the combined treatment is not only effective but also safe for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction of Propofol-Induced Pain through Pretreatment with Lidocaine and/or Flurbiprofen. Fujii, Y., Nakayama, M.[2018]

In a randomized, double-blind trial involving 80 patients, adding 1 ml of lignocaine (10 mg) to 19 ml of propofol significantly reduced the pain associated with propofol injection.

The study demonstrated a statistically significant decrease in both the incidence and severity of injection pain when lignocaine was included, with a P-value of less than 0.01.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The reduction of pain on injection of propofol: the effect of addition of lignocaine. Helbo-Hansen, S., Westergaard, V., Krogh, BL., et al.[2019]

In a study of 120 female patients undergoing gynaecological laparoscopy, the combination of lignocaine (20mg) and ketamine (5mg) significantly reduced the incidence of pain during propofol injection compared to lignocaine alone, with only 10% of patients reporting pain in the combination group versus 40% in the lignocaine/placebo group.

The study found no complications at the injection sites, indicating that the combined treatment is not only more effective but also safe for patients, with no adverse effects observed within the first 24 hours after anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Lignocaine plus Ketamine at Different Doses in the Prevention of Pain Due to Propofol Injection. Fujii, Y., Nakayama, M.[2018]

In a study of 100 patients, the combination of lidocaine and flurbiprofen axetil significantly reduced pain during propofol injection, with only 8% of patients reporting pain compared to 32% with lidocaine alone and 40% with flurbiprofen axetil alone.

The results suggest that using both medications together is more effective than using either one alone, highlighting a potential strategy for improving patient comfort during propofol administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of the lidocaine/flurbiprofen axetil combination for reducing pain during the injection of propofol. Fujii, Y., Itakura, M.[2017]

In a study involving 200 healthy outpatients, the bisulfite-containing formulation of propofol was found to cause less severe pain on injection compared to the brand name Diprivan(TM), with 5% of patients reporting severe pain versus 11% for Diprivan(TM).

Both formulations had similar induction characteristics and safety profiles, making the bisulfite-containing propofol a cost-effective alternative, priced at $13 compared to $15 for Diprivan(TM).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bisulfite-containing propofol: is it a cost-effective alternative to Diprivan for induction of anesthesia? Shao, X., Li, H., White, PF., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Lidocaine is more efficient than the choice of propofol formulations to reduce incidence of pain on induction. [2013]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Reduction of Propofol-Induced Pain through Pretreatment with Lidocaine and/or Flurbiprofen. [2018]

3. England pubmed.ncbi.nlm.nih.gov

The reduction of pain on injection of propofol: the effect of addition of lignocaine. [2019]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Efficacy of Lignocaine plus Ketamine at Different Doses in the Prevention of Pain Due to Propofol Injection. [2018]

5. Italy pubmed.ncbi.nlm.nih.gov

Efficacy of the lidocaine/flurbiprofen axetil combination for reducing pain during the injection of propofol. [2017]

6. United States pubmed.ncbi.nlm.nih.gov

Comparison of lidocaine, metoclopramide, and flurbiprofen axetil for reducing pain on injection of propofol in Japanese adult surgical patients: a prospective, randomized, double-blind, parallel-group, placebo-controlled study. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Modulating effects of lignocaine on propofol. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Clinical therapeutic effects of lidocaine combination with flurbiprofen axetil for reducing propofol-induced pain in adults: A protocol for systematic review and meta-analysis. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Bisulfite-containing propofol: is it a cost-effective alternative to Diprivan for induction of anesthesia? [2019]