Intravenous Lidocaine for Postoperative Pain

Not currently recruiting at 1 trial location

Overseen By Philippe Richebé, MD PhD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Ciusss de L'Est de l'Île de Montréal

Must not be taking: Immunosuppressants, Corticosteroids, NSAIDs

Disqualifiers: Arrhythmia, Pregnancy, Allergy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: Intra-operative, 5 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether intravenous lidocaine (an anesthetic administered through the veins) can reduce pain and the need for opioids after laparoscopic colorectal surgery. Researchers aim to determine its effect on the use of remifentanil during surgery and its impact on immune cell activity for 48 hours afterward. Individuals who have undergone colorectal surgery using the Enhanced Recovery After Surgery (ERAS) program and do not have certain heart conditions or allergies may qualify for this study. Participants will receive either lidocaine or a saline placebo during surgery to compare outcomes. As a Phase 4 trial, this research seeks to understand how this already FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot participate if you are on immunosuppressive treatments, corticosteroids, or long-term NSAIDs (non-steroidal anti-inflammatory drugs) within 48 hours before surgery.

What is the safety track record for intravenous lidocaine (IVL)?

Research has shown that using intravenous lidocaine (IVL) during surgery is generally safe. Studies have found that it can reduce post-surgical pain and decrease the need for opioids, which are strong painkillers. This is beneficial because using fewer opioids can lead to fewer side effects.

Regarding safety, studies have not identified any major safety issues with IVL. Patients who received IVL reported slightly less pain after surgery and experienced fewer stomach and bowel problems, such as temporary blockages. This suggests that most patients tolerate the treatment well.

Since this trial is in a later stage, IVL has likely been tested on many people, providing researchers with a good understanding of its safety. Additionally, the FDA has already approved lidocaine for other uses, such as numbing during dental work, indicating it is generally safe. However, further research is always valuable to fully understand its effects. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike traditional medications for postoperative pain management, such as opioids and NSAIDs, intravenous lidocaine (IVL) offers a unique approach by utilizing local anesthetic properties to reduce pain. Researchers are excited about IVL because it directly targets nerve signals that contribute to pain, potentially minimizing the need for opioids and their associated side effects. Additionally, IVL is administered as a continuous infusion during surgery, allowing it to take effect quickly and consistently, which might lead to better pain control immediately after surgery. This could offer a more efficient and potentially safer alternative for managing postoperative pain.

What evidence suggests that intravenous lidocaine might be an effective treatment for postoperative pain?

Studies have shown that intravenous lidocaine (IVL), which participants in this trial may receive, effectively reduces pain after surgery. Research indicates that it lowers pain levels and decreases the need for opioids, strong painkillers. This treatment also aids in faster recovery by shortening the time for the intestines to resume normal function after surgery. IVL acts as a local anesthetic and provides anti-inflammatory and pain-relief effects. These findings strongly support using IVL for improved pain management after surgery. ^{2 3 6 7 8}

Who Is on the Research Team?

Philippe Richebé, MD, PhD

Principal Investigator

CIUSSS Est de l'ile de Montreal

Are You a Good Fit for This Trial?

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 am older than 18 years.

I am managed under the ERAS program at this center.

I have had surgery on my colon.

Exclusion Criteria

Pregnant women

Inability to complete the questions related to this study

I have a heart rhythm problem but am not on medication for it.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo laparoscopic colorectal surgery with either intravenous lidocaine or placebo administered during anesthesia

Intra-operative, 5 hours

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for postoperative pain, opioid requirements, and immune cell activity for 48 hours

48 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of rehabilitation scores and cognitive functions

7 days

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• intravenous lidocaine (IVL)
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: intravenous lidocaine (IVL) Experimental Treatment 1 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: Placebo Placebo Group 1 Intervention

Will receive the same volume of normal saline for the entire duration of anesthesia.

Who Is Running the Clinical Trial?

Ciusss de L'Est de l'Île de Montréal

Lead Sponsor

Trials

81

Recruited

6,400+

Foundation of Anesthesia and Resuscitation of Quebec

Collaborator

Trials

1

Recruited

60+

Published Research Related to This Trial

Intravenous lidocaine is emerging as a multimodal analgesic therapy that can help reduce the need for opioids after surgery, which is important for improving patient care and safety.

The article provides insights from a Veterans Affairs hospital's experience with implementing intravenous lidocaine, highlighting the need for educational resources and protocols to support nurses in managing this treatment effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Educating Nurses on Intravenous Lidocaine for Postoperative Pain Management. Hunter, OO., Wong, A., Leng, J., et al.[2021]

In a study involving 12 subjects, Xylocaine (lidocaine aerosol 10%) and lidocaine 4% were found to be effective for providing topical anesthesia to the tympanic membrane, with significant pain reduction observed 25 minutes after application.

Lidocaine hydrochloride 5% was ineffective, likely due to its ionized form, which suggests that the un-ionized state of lidocaine is crucial for its anesthetic efficacy, and no side effects were reported during the trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical anaesthesia of the normal tympanic membrane: a controlled clinical trial of different suspensions of lidocaine. Møller, A., Grøntved, A.[2018]

Intraperitoneal (IP) and intravenous (IV) lidocaine significantly reduced postoperative pain and opioid consumption in patients after laparoscopic cholecystectomy, as shown in a randomized trial with 72 participants.

IP lidocaine provided better pain control in the first two hours post-surgery compared to IV lidocaine, but IV lidocaine is more convenient for use in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of intraperitoneal and intravenous lidocaine on pain relief after laparoscopic cholecystectomy. Yang, SY., Kang, H., Choi, GJ., et al.[2022]

In a study of 64 patients undergoing colon surgery, intravenous lidocaine infusion significantly reduced post-operative pain compared to a placebo, with lower pain scores reported during the first 24 hours after surgery.

Patients receiving lidocaine also experienced faster recovery, with quicker resumption of bowel function and a shorter hospital stay by an average of 1.2 days, without increasing the risk of surgery-related complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous lidocaine for post-operative pain relief after hand-assisted laparoscopic colon surgery: a randomized, placebo-controlled clinical trial. Tikuišis, R., Miliauskas, P., Samalavičius, NE., et al.[2021]

A meta-analysis of 14 randomized controlled trials involving 742 patients found that intravenous (IV) lidocaine significantly reduces opiate requirements and pain scores after laparoscopic surgery, indicating its efficacy in postoperative pain management.

IV lidocaine also leads to less nausea and vomiting and allows for quicker resumption of diet, with a low incidence of associated toxicity, suggesting it is a safe option for enhancing recovery after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Intravenous Lidocaine for Postoperative Analgesia Following Laparoscopic Surgery: A Meta-Analysis. Ventham, NT., Kennedy, ED., Brady, RR., et al.[2022]

In a study involving 16 healthy volunteers, intravenous lidocaine at a concentration of 2 mg/mL showed a sustained decrease in ischemic pain ratings, indicating its potential effectiveness in treating acute pain.

While lidocaine had limited effects on electrical pain and no change in thermal pain or normal sensation, the results suggest that it may be beneficial for specific types of pain, particularly ischemic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous lidocaine reduces ischemic pain in healthy volunteers. Frölich, MA., McKeown, JL., Worrell, MJ., et al.[2021]

Intravenous lidocaine infusion significantly reduced postoperative pain intensity for up to 3 months in patients undergoing spinal fusion surgery, as measured by Visual Analog Score (VAS).

Patients receiving lidocaine required significantly less morphine in the first 24 hours post-surgery (4.5 mg vs. 19.85 mg) and had a longer time before needing additional pain relief (9.56 hours vs. 1.82 hours).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of intravenous lidocaine infusion on long-term postoperative pain after spinal fusion surgery. Ibrahim, A., Aly, M., Farrag, W.[2021]

In a study of 298 adult patients receiving intravenous lidocaine for postoperative pain, 58.4% experienced adverse effects, with nausea being the most common, but only 12.8% discontinued treatment due to these effects, indicating that lidocaine is generally well-tolerated.

The use of intravenous lidocaine significantly reduced opioid consumption and pain scores within the first day post-infusion, suggesting it is an effective adjunct for managing postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Safety of Continuous Infusion Lidocaine for Postoperative Pain. Schuler, BR., Lupi, KE., Szumita, PM., et al.[2023]

Intravenous lidocaine (IVL) has been shown to reduce postoperative pain and decrease the need for opioids, along with having anti-inflammatory effects, making it potentially beneficial in perioperative settings.

Despite its promising effects in abdominal surgery, the overall quality of evidence for IVL's benefits across various types of surgeries is limited and inconsistent, leading to uncertainty about its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative Use of Intravenous Lidocaine. Beaussier, M., Delbos, A., Maurice-Szamburski, A., et al.[2019]

A case study highlighted a reproducible anaphylactic reaction to lidocaine hydrochloride, a common local anesthetic used in surgeries, emphasizing the need for caution in patients with potential allergies.

Early intervention with epinephrine, oxygen, and intravenous fluids effectively relieved the symptoms, underscoring the importance of prompt treatment in allergic reactions and the necessity of sensitivity testing before using lidocaine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anaphylactic reaction to lidocaine. Kennedy, KS., Cave, RH.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5144913/

The analgesic efficacy of intravenous lidocaine infusion ... These studies found that IV lidocaine infusion in the perioperative period decreases pain intensity, opioid requirements, the duration of postoperative ileus, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8958859/

Intravenous Lidocaine for Postoperative Analgesia in 90 ... Most studies have concluded that intravenous lidocaine lowers pain scores [19,20], decreases postoperative opioid requirements [19,20], offers ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03921567?cond=Analgesics&viewType=Table&rank=4

Intravenous Lidocaine for Perioperative and Postoperative ... Lidocaine is a local anesthetic and its administration with intravenous routes has analgesic, antihyperalgic and antiinflammatory action. It increases the ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0952818021003639

Association between perioperative intravenous lidocaine ... Our results verified the efficacy of intravenous lidocaine for enhancing postoperative quality of recovery by using a validated subjective tool.

5. journals.lww.com journals.lww.com/mamc/fulltext/2023/09010/evaluation_of_efficacy_of_two_different_doses_of.3.aspx

Evaluation of Efficacy of Two Different Doses of... This study suggests that intravenous lidocaine at a dose of 3 mg/kg or 4 mg/kg was effective in reducing pain in patients with chronic neuropathic pain. Our ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6513586/

Continuous intravenous perioperative lidocaine infusion for ... Primary outcomes. 1. Postoperative pain. In total, 42 studies provided data on postoperative pain; we omitted eight due to suspected variance reporting. The ...

7. mdpi.com mdpi.com/2077-0383/11/12/3543

The Use of Intravenous Lidocaine in Perioperative Medicine Lidocaine's use has been reported to have slightly lower pain scores [52] at one to four hours after surgery, alongside a reduction in postoperative ileus ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5370626/

The efficacy and safety of intravenous lidocaine for analgesia ... They also concluded that intravenous lidocaine peri-operatively reduces post-operative pain and opioid requirements, although further research is required for ...