Local/MAC Anesthesia for Lumbar Spinal Stenosis

Recruiting at 3 trial locations

Overseen By Sarah Miller, MAS

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Stanford University

Must not be taking: Morphine

Disqualifiers: Nerve retraction, Previous fusion, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different types of anesthesia for individuals undergoing surgery to treat lumbar spinal stenosis, a condition that narrows spaces in the spine and can cause pain. Researchers aim to determine if local anesthesia with monitored anesthetic care (a combination of a local numbing agent, such as Lidocaine Hydrochloride, Injectable, and a relaxing medicine) is as effective as general anesthesia, where patients remain unconscious. The trial will compare the effects of each method on surgery outcomes and patient experiences. Individuals with lumbar stenosis surgery planned for 1-3 segments and suitable for general anesthesia may be good candidates. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking medical knowledge.

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.

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

Research has shown that using lidocaine as a local anesthetic during surgery can speed up recovery. It also helps the digestive system return to normal sooner and reduces the risk of complications compared to general anesthesia. Propofol, which keeps patients relaxed and slightly aware during surgery, has proven safe and effective for spine surgeries.

Both lidocaine and propofol have been used in surgeries for a long time, with well-established safety. They are generally well-tolerated, with few side effects reported. Patients undergoing surgery with these anesthetics often experience fewer complications and better outcomes than those receiving general anesthesia. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this trial because it explores different anesthesia techniques for lumbar spinal stenosis surgery. Unlike the standard approach of general anesthesia, which involves full unconsciousness and intubation, the Monitored Anesthetic Care (MAC)/Local method uses a combination of local lidocaine injections and IV propofol to keep patients relaxed but aware. This can potentially lead to a quicker recovery, as it avoids the need for intubation and the deeper sedation associated with general anesthesia. By comparing these two anesthesia methods, the trial aims to find out if MAC/Local can offer a safer and more efficient alternative for patients undergoing surgery for lumbar spinal stenosis.

What evidence suggests that this trial's treatments could be effective for lumbar spinal stenosis?

Research has shown that using lidocaine alone for treating lumbar spinal stenosis might not provide long-lasting benefits. In this trial, one group will receive a combination of lidocaine and propofol under Monitored Anesthetic Care (MAC)/Local anesthesia. Studies have found that combining lidocaine with other treatments works about the same as using lidocaine alone, suggesting its benefits might be limited. In contrast, propofol, used for anesthesia during spinal surgeries, has been linked to less blood loss and quicker recovery. Patients who received propofol also reported feeling less pain after surgery. Overall, propofol seems to improve surgical results, while lidocaine's effectiveness on its own appears limited. ^{6 7 8 9 10}

Who Is on the Research Team?

Todd Alamin, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Lidocaine Hydrochloride, Injectable
• Propofol Injection

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.

How Is the Trial Designed?

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 European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Lidocaine for:

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

Approved in United States as Lidocaine for:

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

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+

Published Research Related to This Trial

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 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]

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 100 Japanese adult surgical patients, pretreatment with lidocaine, metoclopramide, or flurbiprofen axetil significantly reduced the incidence of pain during propofol injection compared to a placebo, with pain incidence dropping from 92% in the placebo group to 24%, 28%, and 36% in the treatment groups respectively.

The effectiveness of lidocaine, metoclopramide, and flurbiprofen axetil in reducing injection pain was comparable, indicating that any of these options can be safely used to minimize discomfort without significant adverse effects.

NCBI (Pubmed)

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. Fujii, Y., Itakura, M.[2022]

The study aims to evaluate the combined effects of lidocaine and flurbiprofen axetil in reducing pain during propofol injection in adults, addressing a common adverse effect of anesthesia.

By systematically reviewing existing literature, this research seeks to provide high-quality evidence and guidance for managing propofol injection pain, potentially improving patient comfort during anesthesia.

NCBI (Pubmed)

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. Sun, W., Yu, J., Lu, G., et al.[2022]

In a study involving 328 patients, adding lidocaine to Lipuro propofol significantly reduced both the incidence and severity of injection pain compared to Lipuro propofol alone and Diprivan with or without lidocaine.

The results indicate that using lidocaine with Lipuro propofol provides a more comfortable induction of anesthesia, making it a preferable option for minimizing pain during injection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lidocaine is more efficient than the choice of propofol formulations to reduce incidence of pain on induction. Mallick, A., Elliot, SC., Krishnan, K., et al.[2013]

Adding 0.05% lignocaine to propofol significantly reduces the pain associated with its injection into hand veins, making the procedure more comfortable for patients.

Higher concentrations of lignocaine do not provide additional benefits in pain reduction or in minimizing excitatory effects, indicating that 0.05% is the optimal dosage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modulating effects of lignocaine on propofol. Tham, CS., Khoo, ST.[2019]

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