Local/MAC Anesthesia for Lumbar Spinal Stenosis
Palo Alto (17 mi)Overseen byTodd Alamin, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: Stanford University
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.
Is the drug Lidocaine Hydrochloride, Injectable, Propofol Injection a promising treatment for pain during anesthesia for lumbar spinal stenosis?Yes, combining Lidocaine with Propofol can help reduce the pain that often happens when Propofol is injected. This makes it a promising option for making anesthesia more comfortable.13468
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking daily morphine equivalents of 100mg or more, you cannot participate.
What safety data exists for using local anesthesia with propofol for lumbar spinal stenosis?The safety data primarily focuses on reducing pain associated with propofol injection. Studies show that adding lignocaine (lidocaine) to propofol significantly reduces pain on injection. Various studies have tested different combinations and dosages of lignocaine with propofol, indicating that lignocaine is effective in reducing pain, although it may not completely eliminate it. The addition of lignocaine also reduces the incidence of excitatory effects during propofol administration.126710
What data supports the idea that Local/MAC Anesthesia for Lumbar Spinal Stenosis is an effective drug?The available research shows that lidocaine, when used with propofol, can reduce the pain associated with propofol injections. For example, one study found that adding lidocaine to propofol significantly reduced the pain experienced during injection. Another study confirmed that lidocaine is effective in reducing pain, although it may not completely eliminate it. However, these studies focus on reducing pain from propofol injections rather than directly addressing the effectiveness of lidocaine for treating lumbar spinal stenosis. Therefore, while lidocaine is effective in reducing injection pain, the research does not provide direct evidence of its effectiveness for lumbar spinal stenosis.14569
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
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.
I am scheduled for a procedure involving significant nerve adjustment.
I have had a spinal fusion surgery before.
Treatment Details
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.
2Treatment groups
Active Control
Group I: Monitored Anesthetic Care (MAC)/LocalActive Control1 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 anesthesiaActive Control1 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 nearbySelect from list below to view details:
Stanford outpatient centerRedwood City, CA
Outpatient Surgery Center/Stanford Spine ClinicRedwood City, CA
Susmita ChatterjeeUnion City, CA
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Who is running the clinical trial?
Stanford UniversityLead Sponsor
References
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).
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.
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
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.
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.
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.
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.
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.
Effect of Lipid Composition in Propofol Formulations: Decisive Component in Reducing the Free Propofol Content and Improving Pharmacodynamic Profiles. [2017]Current endeavor was aimed towards studying significance of lipid composition on free propofol concentration in aqueous phase and associated pain on injection. Three different nanoformulations, namely long-chain triglyceride (LCT)/medium-chain glyceride (MCG)-based nanoemulsion (ProNano), MCG-based self-nanoemulsifying formulation (PSNE), and lipid-free nanoformulation (PNS) were accessed for the same. In vitro and in vivo performances of developed formulations were compared with Diprivan®. ProNano showed minimum free propofol concentration (0.13%) and hence lower pain on injection (rat paw-lick test, 6 ± 2 s) compared to Diprivan®, PSNE, and PNS (0.21%, 0.23%, and 0.51% free propofol, respectively, and rat paw-lick test; 12 ± 3, 14 ± 2, and 22 ± 3 s, respectively). These results conjecture the role of MCG in effective encapsulation of propofol. Anesthetic action assessed by measuring duration of loss of righting reflex (LORR), which was found similar in case of ProNano and PSNE (14 ± 3 and 15 ± 3 min, respectively) compared to Diprivan® (13 ± 3 min). In case of lipid-free formulation, PNS, extended anesthetic action (21 ± 2 min) was observed which may be due to sustained release of propofol from nanosponges. Studies on effect of lipoproteins on propofol release highlighted significance of HDL (100% release with maximum concentration of about 1.2 μg/ml of HDL) from all three formulations.
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.