Intravenous Lidocaine for Postoperative Pain
Recruiting in Palo Alto (17 mi)
Overseen ByPhilippe Richebé, MD, PhD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Ciusss de L'Est de l'Île de Montréal
Prior Safety Data
Trial Summary
What is the purpose of this trial?This study evaluates the impact of intraoperative intravenous lidocaine administered during laparoscopic colorectal surgery on the intraoperative remifentanil consumption as well as postoperative pain and opioid requirements. It will evaluate immune cell activity for 48hours after surgical stress and general anesthesia with or without intravenous lidocaine.
Is the drug intravenous lidocaine a promising treatment for reducing pain after surgery?Yes, intravenous lidocaine is a promising drug for reducing pain after surgery. It has been shown to help with pain relief for days or even weeks after surgery, and it has both pain-relieving and anti-inflammatory effects. This makes it a valuable option for managing pain without relying heavily on opioids.15679
What safety data exists for intravenous lidocaine in postoperative pain management?Intravenous lidocaine (IVL) is generally considered safe for postoperative pain management, with a high therapeutic index and plasma concentrations typically below cardiotoxic and neurotoxic levels when used at recommended doses. However, there are rare cases of anaphylactic reactions, highlighting the importance of sensitivity testing. The safety profile is supported by its rapid distribution and metabolism, and its use is associated with reduced opioid requirements and postoperative pain. Despite these benefits, the quality of evidence is limited, and further research is needed to confirm its safety and efficacy across different surgical contexts.236810
What data supports the idea that Intravenous Lidocaine for Postoperative Pain is an effective treatment?The available research shows that intravenous lidocaine is effective in reducing postoperative pain. For example, one study found that it helps decrease pain and shortens the time it takes for patients to return to normal bowel function after hand-assisted laparoscopic colon surgery. Another study highlighted that it reduces pain for days or even weeks after spinal fusion surgery. Additionally, intravenous lidocaine can lower the need for opioids, which are strong painkillers, and improve overall pain scores. These findings suggest that intravenous lidocaine is a beneficial option for managing pain after surgery.456710
Do I have to stop taking my current medications for the trial?The trial does not specify if you need to stop all current medications, but you cannot be on immunosuppressive treatments, corticosteroids, or long-term NSAIDs before the trial. If you're on these, you might need to stop them 48 hours before the surgery.
Eligibility Criteria
This trial is for adults over 18 undergoing laparoscopic colorectal surgery who are generally healthy (ASA I-III) and follow a specific recovery program (ERAS). It's not for those with heart rhythm problems, on certain medications like antiarrhythmics or immunosuppressives, pregnant women, or anyone allergic to lidocaine or hydromorphone.Inclusion Criteria
I have had surgery on my colon.
Exclusion Criteria
I have a heart rhythm problem but am not on medication for it.
I am not on long-term steroids, NSAIDs, or immunosuppressants.
I am allergic or intolerant to lidocaine, hydromorphone, or any drugs used around the time of surgery.
I cannot use hydromorphone pain control after surgery.
My surgery was changed from keyhole to open surgery while underway.
Participant Groups
The study tests if intravenous lidocaine during surgery can reduce the need for remifentanil (a painkiller) and improve post-surgery pain management. It also looks at how it affects immune function within 48 hours after surgery compared to a placebo.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: intravenous lidocaine (IVL)Experimental Treatment1 Intervention
Will receive during the colorectal surgery under General Anesthesia intravenous lidocaine bolus 1.5mg/kg at the beginning of anesthesia (induction) and 1.5mg/kg/h until the end of anesthesia.
Group II: PlaceboPlacebo Group1 Intervention
Will receive the same volume of normal saline for the entire duration of anesthesia.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Hôpital Maisonneuve-Rosemont, CIUSSS de l'Est de l'Ile de MontréalMontréal, Canada
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Who is running the clinical trial?
Ciusss de L'Est de l'Île de MontréalLead Sponsor
Foundation of Anesthesia and Resuscitation of QuebecCollaborator
References
Topical anaesthesia of the normal tympanic membrane: a controlled clinical trial of different suspensions of lidocaine. [2018]The purpose of this investigation was to find an effective method for topical lidocaine anaesthesia of the tympanic membrane for minor therapeutical procedures. Twelve subjects with healthy ears were tested in a randomized double-blind crossover trial. Xylocaine (lidocaine) aerosol 10%, lidocaine 4%, and lidocaine hydrochloride 5% were tested against placebo. Xylocaine aerosol was sprayed into a small container, shaken, and tempered. This made the application painless. The eardrum was stimulated by a point of a needle effective 25 min after application (p = 0.008 and p less than 0.05, respectively). Lidocaine hydrochloride showed no effect. No side effects were observed. The effectiveness seems to be dependent on the ionization of the drug, since the two effective drugs lidocaine and Xylocaine are un-ionized, whereas the ineffective lidocaine hydrochloride is ionized.
Anaphylactic reaction to lidocaine. [2022]Lidocaine hydrochloride is an amide-type local anesthetic, commonly used for facial plastic as well as other surgical procedures. In an unusual case of reproducible anaphylactic reaction to lidocaine, early treatment with epinephrine, oxygenation, and intravenous fluid resuscitation resulted in relief of the symptoms. This case demonstrates the importance of sensitivity testing and choosing an appropriate alternative local anesthetic in a patient with a history of possible allergy to lidocaine.
Intravenous lidocaine reduces ischemic pain in healthy volunteers. [2021]Lidocaine, a local anesthetic and antiarrhythmic drug that alters depolarization in neurons by blocking the fast voltage-gated sodium (Na+) channels in the cell membrane, is used for regional anesthesia, as antiarrhythmic drug, and as analgesic for various painful conditions. It is unclear whether monotherapy with intravenous lidocaine has an analgesic effect in healthy individuals. To address this important question, we studied pain perception before, during, and after the administration of intravenous lidocaine in 16 human volunteers. Our hypothesis was that lidocaine, administered as a short intravenous infusion, does not have an analgesic effect in healthy volunteers.
Intravenous lidocaine for post-operative pain relief after hand-assisted laparoscopic colon surgery: a randomized, placebo-controlled clinical trial. [2021]Perioperative intravenous (IV) infusion of lidocaine has been shown to decrease post-operative pain, shorten time to return of bowel function, and reduce the length of hospital stay. This randomized, prospective, double-blinded, placebo-controlled clinical trial evaluated the impact of IV lidocaine on the quality of post-operative analgesia and other outcomes after hand-assisted laparoscopic colon surgery.
Efficacy of intraperitoneal and intravenous lidocaine on pain relief after laparoscopic cholecystectomy. [2022]This randomized, double-blind, placebo-controlled trial evaluated intraperitoneal (IP) lidocaine administration and intravenous (IV) lidocaine infusion for postoperative pain control after laparoscopic cholecystectomy (LC).
Efficacy of Intravenous Lidocaine for Postoperative Analgesia Following Laparoscopic Surgery: A Meta-Analysis. [2022]Intravenous (IV) lidocaine has analgesic and anti-inflammatory properties. This study aims to evaluate the efficacy of IV lidocaine in controlling postoperative pain following laparoscopic surgery.
Effect of intravenous lidocaine infusion on long-term postoperative pain after spinal fusion surgery. [2021]Intravenous lidocaine infusion is known to reduce postoperative pain for days or weeks beyond the infusion time, and plasma half-life in several types of surgical procedures.
Perioperative Use of Intravenous Lidocaine. [2019]Lidocaine is an amide local anaesthetic initially used intravenously as an antiarrhythmic agent. At some point it was proposed that intravenous lidocaine (IVL) had an analgesic effect that could be potentially beneficial in perioperative settings. Since these preliminary reports, a large body of evidence confirmed that IVL had anti-inflammatory and opiate-sparing effects, a combination of characteristics leading to an array of effects such as a decrease in postoperative pain and opiate consumption, and a reduction in the duration of digestive ileus. Additional studies demonstrated IVL to possess antithrombotic, antimicrobial and antitumoral effects. Beneficial effects of IVL have been characterized in abdominal surgery but remain controversial in other types of surgeries. Because the quality of evidence was limited, due to inconsistency, imprecision and study quality, recent conclusions from meta-analysis pooling together all types of surgery stated the uncertainty about IVL benefits. Additional indications such as the prevention of propofol-induced injection pain, prevention of hyperalgesia, protection against bronchial reactivity by bronchotracheal relaxation during surgery, and the increase in depth of general anaesthesia have since emerged. IVL is rapidly distributed in the body and metabolized by the liver. With the commonly recommended doses, lidocaine's therapeutic index remains very high and the plasma concentrations stay largely below the cardiotoxic and neurotoxic threshold levels, a notion that may be used by clinicians to draw conclusions on the benefit-risk profile of IVL in comparison to other analgesic strategies. The purpose of this review is to address the pharmacokinetic and pharmacodynamic properties of lidocaine in healthy and pathological conditions.
Educating Nurses on Intravenous Lidocaine for Postoperative Pain Management. [2021]As healthcare practitioners continue to search for multimodal analgesic therapies to reduce postoperative opioid requirements, surgical ward nurses need to stay up to date on the status of emerging therapies. One of these is intravenous lidocaine for postoperative pain management. Unfortunately, there is a lack of resources to assist surgical ward nurses who are unfamiliar with lidocaine infusions for pain. This article aims to review the pharmacology of intravenous lidocaine for pain management, describe an experience of a university-affiliated Veterans Affairs hospital with implementation of intravenous lidocaine on the surgical ward, and suggest practical tools that can be used to develop protocols and educational content for nurses managing intravenous lidocaine infusions in the postoperative period.
Evaluating the Safety of Continuous Infusion Lidocaine for Postoperative Pain. [2023]The aim was to evaluate the safety of intravenous lidocaine for postoperative pain and the impact on opioid requirements and pain scores.