Atrium Health is hosting a clinical trial that studies IV lidocaine’s effect on postoperative pain in patients with paraesophageal hernia repairs. Participants from the Carolinas Hernias Center outpatient clinic will be involved in the study for 6 months. Pain will be documented using the visual analog scale (VAS). This is the standard nursing method of reporting patient pain levels where they describe pain as being from 0 (no pain) to 10 (excruciating pain). The study’s estimated completion date is January 1, 2021.
There will be an estimated 50 participants in this study. They will be randomly assigned to one of two groups: a group infused with lidocaine and a group infused with a placebo. Researchers will observe how much each group needs morphine after their operations, their VAS pain scores, how quickly bowel functions return, and how well they tolerate a normal diet. Researchers hypothesize that the lidocaine group will need less narcotics and may have earlier discharge dates.
All sexes, ages 18 and older, are allowed to participate. Other conditions that must be met to be included are:
- Fit American Association of Anesthesiologists (ASA) scores of I-III
- Are 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.
Those not allowed to participate include:
- Patients with end stage renal disease
- Patients with allergies to lidocaine and other amide local anesthetics.
- Patients with have reason to withhold sodium channel blockers in treatment.
- Patients with slower thought processes and reduced physical movements, defined as psychomotor retardation
- Patients with a body mass index greater than 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 procedures at the same time as this study, other than paraesophageal hernia repair (PEH).
- Patients that are classified as ASA 4 or 5 during preoperative anesthesia visit (if needed).
Exclusion from all or portions of this study will be determined by the attending surgeon and anesthesiologist.
Those interested may participate in this study at Atrium Health – Carolinas Medical Center in Charlotte, North Carolina, 28203. Feel free to contact Kathleen Roeing, MS at 704-355-6682 or at firstname.lastname@example.org with any questions or concerns.
This clinical trial is sponsored by Atrium Health.
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