Intravenous Lidocaine for Postoperative Pain

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

60 Participants Needed

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.

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 data supports the effectiveness of the drug intravenous lidocaine for postoperative pain relief?

Research shows that intravenous lidocaine can help reduce pain after surgery, shorten the time it takes for the bowel to start working again, and decrease the length of hospital stays. It also has been found to lower the need for opioids (strong painkillers) and improve pain control after various types of surgeries. ^{1 2 3 4 5}

Is intravenous lidocaine generally safe for humans?

Intravenous lidocaine is generally considered safe when used at recommended doses, as it is rapidly processed by the body and stays below harmful levels. However, there is a rare risk of allergic reactions, so sensitivity testing is important. ^{1 5 6 7 8}

How does intravenous lidocaine differ from other drugs for postoperative pain?

Intravenous lidocaine is unique because it not only helps reduce pain immediately after surgery but can also continue to relieve pain for days or weeks beyond the infusion time. Unlike many pain medications that are taken by mouth or injected into the muscle, lidocaine is given directly into the bloodstream, which can enhance its effectiveness in managing pain and reducing inflammation. ^{1 3 4 9 10}

Research Team

Philippe Richebé, MD, PhD

Principal Investigator

CIUSSS Est de l'ile de Montreal

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 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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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 (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]

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]

References

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

Efficacy of Intravenous Lidocaine for Postoperative Analgesia Following Laparoscopic Surgery: A Meta-Analysis. [2022]

2. Italy pubmed.ncbi.nlm.nih.gov

Intravenous lidocaine for post-operative pain relief after hand-assisted laparoscopic colon surgery: a randomized, placebo-controlled clinical trial. [2021]

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

Efficacy of intraperitoneal and intravenous lidocaine on pain relief after laparoscopic cholecystectomy. [2022]

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

Effect of intravenous lidocaine infusion on long-term postoperative pain after spinal fusion surgery. [2021]

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

Evaluating the Safety of Continuous Infusion Lidocaine for Postoperative Pain. [2023]

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

Anaphylactic reaction to lidocaine. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Intravenous lidocaine reduces ischemic pain in healthy volunteers. [2021]

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

Perioperative Use of Intravenous Lidocaine. [2019]

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

Educating Nurses on Intravenous Lidocaine for Postoperative Pain Management. [2021]

10. Switzerland pubmed.ncbi.nlm.nih.gov

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