Improving Pain Control in Paraesophageal Hernia Repair: Intravenous Lidocaine Versus Placebo
Wake Forest University Health Sciences
50 participants
Jun 21, 2018
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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.
- 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 Criteria11
- 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.
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Interventions
Patients randomized to the IV lidocaine group will receive a 100 mg lidocaine bolus on induction then an infusion of 1.5 mg/kg/hr prior to incision. This infusion will continue throughout operation and into the PACU for 1 hour OR until the 2gm/250 mL D5W bag has been infused, whichever occurs first.
o Patients randomized to the placebo group will receive D5W solution (as this is the carrier for lidocaine) at the same volume and rate as the IV lidocaine.
Locations(1)
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NCT04096170