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

  • STATUS
    Recruiting
  • End date
    Jul 1, 2024
  • participants needed
    50
  • sponsor
    Wake Forest University Health Sciences
Updated on 30 June 2022
Accepts healthy volunteers

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.

Description

Patients will be prospectively enrolled from Carolinas Hernia Center's outpatient clinic. All paraesophageal hernia patients, age 18 and older, undergoing PEH repair at CHS will be included. We will conduct a two-arm prospective randomized study, IV Lidocaine versus placebo, to study the reduction of narcotics, return to bowel function and length of stay. Both arms will receive standard multimodal pain control in the operative and postoperative period. There will be two arms: 1. IV Lidocaine 2. Placebo. Subject participation will last approximately 6 months for this study. Lidocaine will be used as a perioperative adjunct. At the conclusion of the study, chart review will be performed to evaluate if Lidocaine infusion limited narcotic need, or effected Visual Analog Scale (VAS) values. VAS is the standard nursing method of documenting pain using pain scores. The nurses ask the patient to rate pain from 0 (no pain) to 10 (excruciating pain). LOS is a secondary endpoint of the study, as subjects in the lidocaine arm are hypothesized to have improved pain control and require lower narcotic dosing, potentially leading to earlier discharge. We will evaluate patient demographics, preoperative lab values, intraoperative and perioperative variables, as well as postoperative outcomes and pain reported by VAS. Postoperative data to be reviewed will also include total opioid analgesia administered, time from surgery to a clear liquid diet, time from surgery to a post-fundoplication diet, time to return of bowel function, length of stay, pain/VAS scores at 6 hours postoperatively, pain/VAS scores on each post-operative day until discharge, pain/VAS scores at 2 and 4 weeks, and pain/VAS scores at 6 months, infectious complications (urinary tract infections as well as surgical site infections, deep organ space infections, pneumonia), and non-infectious complications (stroke, myocardial infarction, respiratory failure, post-op bleeding, unplanned return to the OR, acute renal failure, death, etc.). When results of the study are published, the subject's identity will remain confidential. Data will be analyzed using standard statistical methods; all patient-identifying information will be removed prior to analysis. Descriptive statistics including means and standard deviations, medians and interquartile range, or counts and percentages, will be used to describe the study population on all variables. For continuous variables comparisons will be made between groups using t-tests and Wilcoxon Rank Sum test. For categorical variables, Chi-Square test and Kruskal-Wallis tests will be used for comparisons between groups. Multivariate regression will be performed as needed to control for potential confounding factors such as age, gender and type of procedure. A p-value of <0.05 will be used for all significance determinations. The SAS® system version 9.4 (Cary, NC) or similar program will be used to complete all statistical analyses.

Details
Condition Hernia, Paraesophageal
Treatment Placebo, IV lidocaine, IV lidocaine
Clinical Study IdentifierNCT04096170
SponsorWake Forest University Health Sciences
Last Modified on30 June 2022

Eligibility

Yes No Not Sure

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) 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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