IV Lidocaine for Hernia Repair
(PEH 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?
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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either IV Lidocaine or placebo during the perioperative period to study its impact on postoperative pain control
Postoperative Monitoring
Participants are monitored for pain control, narcotic use, and recovery milestones such as return of bowel function and diet tolerance
Follow-up
Participants are monitored for long-term outcomes including pain scores and complications
Treatment Details
Interventions
- IV lidocaine
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Atrium Health
Lead Sponsor
Wake Forest University Health Sciences
Lead Sponsor