Improving Pain Control in Paraesophageal Hernia Repair: Intravenous Lidocaine Versus Placebo (NCT04096170) | Clinical Trial Compass
CompletedPhase 4
Improving Pain Control in Paraesophageal Hernia Repair: Intravenous Lidocaine Versus Placebo
United States16 participantsStarted 2018-06-21
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients aged 18+ years of age
* American Association of Anesthesiologists (ASA) scores of I-III
* Undergoing elective laparoscopic paraesophageal hernia repair including robotic assisted laparoscopic cases.
* All paraesophageal hernia patients seen in clinic who meet inclusion criteria will be given the option to enroll.
* Cases converted to open laparotomy or hand-assisted laparoscopy will be included for intention to treat analysis.
* Patients who have complications of Clavien-Dindo class 3 or greater will be included in calculations of complication rates. However, they will not be included in calculations of postoperative morphine equivalents, as repeat intervention will confound the normal course of postoperative pain control.
Exclusion Criteria:
* Patients with end stage renal disease
* Patients with allergies to lidocaine and other amide local anesthetics.
* Patients with contraindications to sodium channel blockers.
* Patients with psychomotor retardation
* Patients with body mass index \>40 mg/kg2.
* Patients receiving opioid pain medication in the previous week or taking daily medication for chronic pain
* Patients with a seizure disorder
* Patients with cardiac intraventricular conduction delays, congestive heart failure, first and second-degree heart conduction blocks.
* Patients undergoing planned concomitant procedures other than PEH repair
* Patients that are classified as ASA 4 or 5 during pre-operative anesthesia visit (if needed) wil…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.