IV Lidocaine for Hernia Repair

(PEH Trial)

Overseen By Greg Scarola

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Atrium Health

Must not be taking: Opioids

Disqualifiers: End stage renal disease, Seizure disorder, BMI >40, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Perioperative period

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how IV lidocaine, a local anesthetic, might help control pain after paraesophageal hernia repair surgery. Researchers aim to determine if lidocaine can improve recovery, reduce hospital stay, and enhance overall quality of life compared to usual pain management methods. Participants will receive either IV lidocaine or a placebo (a treatment with no active drug) during their surgery. Suitable candidates for this trial are those undergoing elective laparoscopic paraesophageal hernia repair who have not taken opioid pain medication in the past week. As a Phase 4 trial, this research focuses on understanding how this FDA-approved and effective treatment can benefit more patients.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop your current medications. However, if you are taking opioid pain medication or daily medication for chronic pain, you cannot participate in the trial.

What is the safety track record for IV lidocaine?

Research has shown that IV lidocaine is usually safe for people. Studies have found that lidocaine can reduce pain after surgery, with some patients experiencing less pain in the hours afterward. Safety data from several studies indicate a low risk of complications with lidocaine, with serious side effects being rare, occurring in only 0.2% to 3% of cases.

Additionally, the FDA has already approved lidocaine for other uses, which adds confidence in its safety. In past trials, some patients experienced minor side effects like dizziness or tingling, but these were uncommon. Overall, IV lidocaine appears to be a safe choice for managing pain after surgery. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard of care for hernia repair, which often involves opioid pain management, IV lidocaine offers a non-opioid alternative for pain control. This treatment is unique because it works by blocking nerve signals to reduce pain during and after surgery, potentially minimizing the need for opioids and their associated side effects. Researchers are excited about IV lidocaine because it is administered directly into the bloodstream, allowing for rapid action and precise dosage, which may lead to faster recovery and improved patient comfort.

What evidence suggests that IV lidocaine might be an effective treatment for postoperative pain control in hernia repair?

Research has shown that IV lidocaine, which participants in this trial may receive, can help reduce pain after surgery. In studies, patients who received IV lidocaine reported less pain following hernia surgeries. For example, one study found it eased pain after inguinal hernia repair, facilitating recovery. Another study demonstrated that lidocaine patches, which function similarly to IV lidocaine, effectively managed pain after hernia repairs. Overall, IV lidocaine has proven to be a helpful option for post-surgical pain relief. ^{2 5 6 7 8}

Who Is on the Research Team?

Paul D Colavita, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for adults over 18 undergoing elective laparoscopic paraesophageal hernia repair. Candidates must have an ASA score of I-III and not be on opioid pain medication or daily chronic pain medication. Exclusions include those with seizure disorders, certain heart conditions, severe kidney disease, recent opioid use, planned additional surgeries, extreme obesity (BMI >40), lidocaine allergies, or contraindications to sodium channel blockers.

Inclusion Criteria

I have a paraesophageal hernia and meet the study's requirements.

My surgery was changed to an open procedure or assisted with hands.

My health is good to moderate, as rated by an anesthesiologist.

Exclusion Criteria

Patients that are classified as ASA 4 or 5 during pre-operative anesthesia visit (if needed) will be excluded. Documentation from the pre-op visit will be reviewed by the research team prior to the surgery date

I have been taking opioid pain medication or daily medication for chronic pain in the last week.

I cannot take medications that block sodium channels due to health reasons.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either IV Lidocaine or placebo during the perioperative period to study its impact on postoperative pain control

Perioperative period

In-person visits during surgery and immediate postoperative period

Postoperative Monitoring

Participants are monitored for pain control, narcotic use, and recovery milestones such as return of bowel function and diet tolerance

Up to 6 months

Regular follow-up visits to assess pain and recovery

Follow-up

Participants are monitored for long-term outcomes including pain scores and complications

6 months

What Are the Treatments Tested in This Trial?

Interventions

• IV lidocaine
• Placebo

Trial Overview The study tests if IV lidocaine improves postoperative pain control in patients having paraesophageal hernia repairs compared to a placebo. It will assess the effect on recovery outcomes like hospital stay length, complications rates, and quality of life within an Enhanced Recovery After Surgery (ERAS) protocol.

How Is the Trial Designed?

Group I: IV Lidocaine Experimental Treatment 1 Intervention

100 mg Lidocaine bolus on induction, then an infusion of 1.5 mg/kg/hr to begin prior to incision, run throughout the operation and continues into PACU for 1 hour OR until one 2gm/250mL D5W bag has been infused, whichever occurs first. The Patient will be monitored by nursing staff with the aid of continuous cardiac monitoring in the PACU for at least 30 minutes after the discontinuation of the lidocaine drip.

Group II: Placebo Placebo Group 1 Intervention

Patients will receive D5W solution at the same volume and rate as the IV lidocaine.

Who Is Running the Clinical Trial?

Atrium Health

Lead Sponsor

Trials

122

Recruited

34,900+

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Published Research Related to This Trial

In a study of 120 patients undergoing inguinal hernia repair, a lower concentration of 0.25% lidocaine provided similar pain relief and satisfaction compared to higher concentrations of 0.33% and 0.5%.

Using the lower concentration of lidocaine not only reduced the total dose consumed but also potentially lowered the risk of local anaesthetic toxicity, making it a safer option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low concentrations of lidocaine for inguinal hernia repair under local infiltration anaesthesia. Song, Y., Han, B., Lei, W., et al.[2013]

In a study involving 16 healthy volunteers, the 5% lidocaine medicated plaster significantly reduced pain sensitivity in both capsaicin and sunburn pain models, with a 53% reduction in pinprick hyperalgesia for capsaicin and an impressive 84% reduction for sunburn.

The lidocaine plaster was effective in alleviating mechanical hyperalgesia and cold pain perception, but it did not affect spontaneous pain or other pain responses, indicating its targeted analgesic action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antihyperalgesic efficacy of 5% lidocaine medicated plaster in capsaicin and sunburn pain models--two randomized, double-blinded, placebo-controlled crossover trials in healthy volunteers. Gustorff, B., Hauer, D., Thaler, J., et al.[2013]

Lidocaine and mexiletine are effective in relieving neuropathic pain, showing significant superiority over placebo in a meta-analysis of 27 trials involving 706 patients.

Both medications have a safety profile similar to other common analgesics like morphine and gabapentin, with the most frequent side effects being drowsiness, fatigue, nausea, and dizziness, but no major adverse events reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systemic administration of local anesthetics to relieve neuropathic pain: a systematic review and meta-analysis. Tremont-Lukats, IW., Challapalli, V., McNicol, ED., et al.[2021]

In a study of 60 patients undergoing colorectal surgery, perioperative systemic lidocaine significantly improved gastrointestinal motility and reduced the length of hospital stay by one day, indicating its efficacy in postoperative recovery.

Lidocaine treatment also attenuated the inflammatory response by lowering levels of pro-inflammatory mediators, suggesting that its anti-inflammatory properties may contribute to better patient outcomes after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systemic lidocaine shortens length of hospital stay after colorectal surgery: a double-blinded, randomized, placebo-controlled trial. Herroeder, S., Pecher, S., Schönherr, ME., et al.[2022]

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]

In a study involving 75 adult patients, both intravenous (IV) and intramuscular (IM) administration of lidocaine effectively reduced the required dose of propofol for anesthesia induction, with no significant difference in propofol doses between the two lidocaine methods.

The control group that received only propofol required a significantly higher dose for anesthesia induction, highlighting the efficacy of lidocaine in enhancing the comfort and effectiveness of anesthesia without any observed side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of intramuscular and intravenous lidocaine on propofol induction dose. Kelsaka, E., Karakaya, D., Baris, S., et al.[2013]

In a study of 40 patients undergoing major abdominal surgery, perioperative administration of lidocaine significantly reduced postoperative pain during movement and decreased morphine consumption in the first 72 hours after surgery, indicating its effectiveness as an analgesic.

The opioid-sparing effect of lidocaine was most notable on the third postoperative day, suggesting that it may help prevent central hyperalgesia, which is an increased sensitivity to pain, by targeting specific nociceptors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative intravenous lidocaine has preventive effects on postoperative pain and morphine consumption after major abdominal surgery. Koppert, W., Weigand, M., Neumann, F., et al.[2022]

Intravenous lidocaine significantly improves the quality of recovery after surgery, as measured by the QoR-40 questionnaire, with a mean difference of 9.65 points compared to placebo across 14 trials involving 1148 patients.

The use of intravenous lidocaine also leads to a notable reduction in intraoperative opioid consumption, specifically remifentanil, without increasing the risk of chronic postsurgical pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between perioperative intravenous lidocaine and subjective quality of recovery: A meta-analysis of randomized controlled trials. Hung, KC., Chu, CC., Hsing, CH., et al.[2022]

Intravenous lidocaine infusion significantly reduces postoperative pain intensity and opioid consumption in patients undergoing abdominal surgery, with pain scores lower for up to 48 hours post-surgery and opioid use reduced by up to 85%.

Lidocaine infusion also promotes faster recovery of bowel function, leading to earlier rehabilitation and a shorter hospital stay, averaging 1.1 days less compared to controls, without causing significant adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of intravenous lidocaine infusion on postoperative analgesia and recovery from surgery: a systematic review of randomized controlled trials. McCarthy, GC., Megalla, SA., Habib, AS.[2022]

Lidocaine has potential benefits beyond traditional anesthesia, including analgesic and immune-modulatory effects, which may be useful in managing cancer, inflammation, and chronic pain.

There is ongoing debate regarding the safety and toxicity of intravenous lidocaine, particularly in its role as part of opioid-sparing strategies during surgery, highlighting the need for careful consideration in clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Intravenous Lidocaine in Perioperative Medicine: Anaesthetic, Analgesic and Immune-Modulatory Aspects. Lee, IW., Schraag, S.[2022]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1743919108001453

Early experience with lidocaine patch for postoperative ... The use of a lidocaine patch in the management of postoperative pain following laparoscopic ventral herniorraphy is a safe and promising modality to consider.

2. withpower.com withpower.com/trial/phase-4-hernia-hiatal-5-2018-4e458

IV Lidocaine for Hernia Repair (PEH Trial) In a study of 120 patients undergoing inguinal hernia repair, a lower concentration of 0.25% lidocaine provided similar pain relief and satisfaction compared to ...

3. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/147323001103900211

Intravenous Lidocaine for Effective Pain Relief after ... It is concluded that intravenous lidocaine injection reduced post-operative pain after inguinal herniorrhaphy, is easy to administer and may ...

4. mdpi.com mdpi.com/2077-0383/8/11/2014

Systemic Lidocaine Infusion for Post-Operative Analgesia ... 4. Discussion. Our findings demonstrate that intravenous lidocaine infusion reduced the severity of the pain measured by the FLACC score in ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9465907/

Efficacy and safety of 5% lidocaine patches ... Another study of 30 patients who underwent laparoscopic ventral hernia repair also found that lidocaine patches are effective for postoperative pain management ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27199310/

a systematic review with trial sequential analysis Meta-analysis suggested that lidocaine reduced postoperative pain (visual analogue scale, 0 to 10 cm) at 1-4 h (MD -0.84, 95% CI -1.10 to -0.59) and at 24 h (MD ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12105344/

The feasibility and safety of ventral hernia repairs under ... Overall, 18 studies specifically assessed the safety and post-operative complication rates between 0.2 and 3%. Some studies reported ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT07076641

Efficacy and Safety of Intravenous Lidocaine Versus ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a ...