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}

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 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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Stanford outpatient center Redwood City, CA

Outpatient Surgery Center/Stanford Spine Clinic Redwood City, CA

Susmita Chatterjee Union City, CA

Who Is Running the Clinical Trial?

Stanford University Lead Sponsor

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] Propofol is associated with pain on injection. It is common practice to premix lidocaine with propofol prior to injection. Lipuro propofol, a propofol emulsified in medium- and long-chain triglycerides, has been shown to reduce the intensity of injection pain compared to Diprivan, although a number of studies report no reduction in overall incidence of pain.

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

Reduction of Propofol-Induced Pain through Pretreatment with Lidocaine and/or Flurbiprofen. [2018] Pain is a well recognised complication of propofol injection. The purpose of this study was to compare the efficacy of flurbiprofen, lidocaine and a combination of the two in reducing pain on injection of propofol.

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

The reduction of pain on injection of propofol: the effect of addition of lignocaine. [2019] The effects of addition of 1 ml of lignocaine (10 mg) or isotonic saline to 19 ml of the emulsified preparation of propofol (Diprivan) were studied in a randomised, double-blind trial in 80 patients. The incidence and severity of pain on injection of propofol were significantly reduced by the addition of lignocaine (P less than 0.01).

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] Pain on injection is still a major problem with propofol. Lignocaine (lidocaine) is effective in preventing propofol-induced pain on injection, but cannot entirely control the pain. The purpose of this study was to examine the effect of lignocaine plus ketamine, an N-methyl-D-aspartate receptor antagonist, on pain on injection of propofol.

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

Efficacy of the lidocaine/flurbiprofen axetil combination for reducing pain during the injection of propofol. [2017] Pain during the injection of propofol is a common clinical problem. Lidocaine pretreatment, preceded by venous occlusion, is the most popular method for reducing pain during the injection of propofol but cannot entirely control such pain. We aimed to evaluate the efficacy of lidocaine, flurbiprofen axetil (an injectable prodrug of flurbiprofen), and the two in combination for reducing pain during the injection of propofol.

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] Pain on injection is a recognized adverse event (AE) of propofol administration for the induction of general anesthesia. Pretreatment with lidocaine, metoclopramide, or flurbiprofen axetil has been reported to be effective in reducing propofol-induced pain. However, no studies comparing the efficacy of these 3 drugs for preventing pain on injection of propofol have been identified.

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

Modulating effects of lignocaine on propofol. [2019] Pain is a well known complication of propofol injection. Premixing with lignocaine 0.1 mg.kg-1 and injection into a large forearm vein has been recommended. The amount of lignocaine to be added is often empirical when the vein on the dorsum of the hand is used. In this study we attempt to determine the optimal amount of lignocaine necessary to reduce pain when propofol is injected into a hand vein. Our study shows that a propofol emulsion containing 0.05% lignocaine is effective in reducing the incidence of propofol injection pain. The addition of lignocaine also reduces the incidence of excitatory effects. Increasing the dosage of lignocaine above 0.05% does not improve the results.

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] Pain on injection is a well-recognized adverse event of propofol administration for the stimulation of general anesthesia. Pre-treatment with lidocaine or flurbiprofen axetil has proven to be effectual in the reduction propofol-induced pain in adults. Nonetheless, only few studies have evaluated the clinical therapeutic effects of lidocaine combination with flurbiprofen axetil to prevent pain on injection of propofol. The current study aims to evaluate the clinical therapeutic effects of lidocaine combination with flurbiprofen axetil to reduce pain on injection of propofol among adult patients.

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

Bisulfite-containing propofol: is it a cost-effective alternative to Diprivan for induction of anesthesia? [2019] Propofol (Diprivan(TM); AstraZeneca, Wilmington, DE) is a commonly used drug for the induction of general anesthesia in the ambulatory setting. With the availability of a new bisulfite-containing generic formulation of propofol, questions have arisen regarding its cost effectiveness and safety compared with Diprivan(TM). Two hundred healthy outpatients were randomly assigned, according to a double-blinded protocol, to receive either Diprivan(TM) or bisulfite-containing propofol 1.5 mg/kg IV as part of a standardized induction sequence. Maintenance of anesthesia consisted of either desflurane (4%-8% end-tidal) or sevoflurane (1%-2% end-tidal) in combination with a remifentanil infusion (0.125 microg x kg(-1) x min(-1) IV). Patient assessments included pain on injection, induction time, hemodynamic and bispectral electroencephalographic changes during induction, emergence time, and incidence of postoperative nausea and vomiting. The two propofol groups were comparable demographically, and the induction times and bispectral index values during the induction were also similar. However, the bisulfite-containing formulation was associated with less severe pain on injection (5% vs 11%), with fewer patients recalling pain on injection after surgery (38% vs. 51%, P