Improving Pain Control in Paraesophageal Hernia Repair: Intravenous Lidocaine Versus Placebo

Completed · Phase 4 · Has a placebo group

Conditions studied: Hernia, Paraesophageal

In brief

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.

Key facts

Study ID

NCT04096170

Run by

Wake Forest University Health Sciences

People needed

16

Starts

2018-06-21

Expected to finish

2024-04-24

Last updated by the study team

2026-06-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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) will be excluded. Documentation from the pre-op visit will be reviewed by the research team prior to the surgery date.
• Exclusion from all or portions will be at the discretion of the attending surgeon and anesthesiologist.

Where it is running

• Atrium Health - Carolinas Medical Center — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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