50 Participants Needed

IV Lidocaine for Hernia Repair

(PEH Trial)

CE
GS
Overseen ByGreg Scarola
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

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 data supports the idea that the drug IV Lidocaine for Hernia Repair is an effective treatment?

The available research shows that IV Lidocaine can be effective in reducing pain and the need for other pain medications after surgery. For example, in abdominal surgeries, patients who received IV Lidocaine reported less pain and used fewer painkillers compared to those who did not receive it. They also recovered faster, with their digestive systems returning to normal sooner, and they spent less time in the hospital. However, the benefits of IV Lidocaine are not as clear for other types of surgeries, and more research is needed to confirm its effectiveness in those cases.12345

What safety data exists for IV lidocaine in hernia repair?

IV lidocaine has been studied for its analgesic, anti-inflammatory, and opiate-sparing effects in perioperative settings, including abdominal surgeries. It is rapidly distributed and metabolized, with plasma concentrations typically below toxic levels at recommended doses. However, the quality of evidence is limited, and benefits remain uncertain for some surgeries. Safety concerns include potential toxicity and medico-legal issues, but it generally has a high therapeutic index.12367

Is the placebo a promising drug for hernia repair?

The placebo is not a promising drug for hernia repair. Placebos are inactive substances used to compare against actual treatments in studies. They don't have any therapeutic effects on their own.128910

What is the purpose of this trial?

We aim to study the impact of perioperative IV lidocaine on postoperative pain control in patients undergoing paraesophageal hernia repair. This is in the context of an established ERAS protocol. We wish to study the effect of IV Lidocaine on postoperative short and long-term outcomes, including patients' length of stay postoperative mortality, morbidity, and quality of life. We will compare this to our standard pain management.

Research Team

PD

Paul D Colavita, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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.
See 2 more

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.
See 8 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: IV LidocaineExperimental Treatment1 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: PlaceboPlacebo Group1 Intervention
Patients will receive D5W solution at the same volume and rate as the IV lidocaine.

Find a Clinic Near You

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+

Findings from Research

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.
Low concentrations of lidocaine for inguinal hernia repair under local infiltration anaesthesia.Song, Y., Han, B., Lei, W., et al.[2013]
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.
Perioperative Use of Intravenous Lidocaine.Beaussier, M., Delbos, A., Maurice-Szamburski, A., et al.[2019]
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.
The Use of Intravenous Lidocaine in Perioperative Medicine: Anaesthetic, Analgesic and Immune-Modulatory Aspects.Lee, IW., Schraag, S.[2022]

References

Low concentrations of lidocaine for inguinal hernia repair under local infiltration anaesthesia. [2013]
Perioperative Use of Intravenous Lidocaine. [2019]
The Use of Intravenous Lidocaine in Perioperative Medicine: Anaesthetic, Analgesic and Immune-Modulatory Aspects. [2022]
Impact of intravenous lidocaine infusion on postoperative analgesia and recovery from surgery: a systematic review of randomized controlled trials. [2022]
Systemic lidocaine shortens length of hospital stay after colorectal surgery: a double-blinded, randomized, placebo-controlled trial. [2022]
Systemic administration of local anesthetics to relieve neuropathic pain: a systematic review and meta-analysis. [2021]
Association between perioperative intravenous lidocaine and subjective quality of recovery: A meta-analysis of randomized controlled trials. [2022]
Effect of intramuscular and intravenous lidocaine on propofol induction dose. [2013]
Perioperative intravenous lidocaine has preventive effects on postoperative pain and morphine consumption after major abdominal surgery. [2022]
Antihyperalgesic efficacy of 5% lidocaine medicated plaster in capsaicin and sunburn pain models--two randomized, double-blinded, placebo-controlled crossover trials in healthy volunteers. [2013]
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