A Phase 4 interventional study of IV lidocaine and Placebo in Hernia, Paraesophageal, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-23.
Sponsored by Wake Forest University Health Sciences · Phase 4, Interventional, and Treatment
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.
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.
Exclusion Criteria:
100 mg Lidocaine bolus on induction, then an infusion of 1.5 mg/kg/hr to begin prior to incision, run throughout the operation and continues into PACU for 1 hour OR until one 2gm/250mL D5W bag has been infused, whichever occurs first. The Patient will be monitored by nursing staff with the aid of continuous cardiac monitoring in the PACU for at least 30 minutes after the discontinuation of the lidocaine drip.
Drug: IV lidocaine
Patients will receive D5W solution at the same volume and rate as the IV lidocaine.
Drug: Placebo
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.
Postoperative Morphine Equivalents
Postoperative consumption of morphine equivalents
Time frame: Post-operation up to 48 hours
Visual Analogue Scale Pain Score
Visual Analogue Scale pain score 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).
Time frame: post-op to 6 months
Length of Stay
Length of postoperative stay
Time frame: up to 1 week
Return of Bowel Function
We will track when each patient passes first bowel movement
Time frame: up to week 1
Hours to Toleration of Diet
Number of hours until patient tolerates a normal diet
Time frame: up to day 2
| Milestone | IV Lidocaine | Placebo |
|---|---|---|
| Started | 8 | 8 |
| Completed | 8 | 7 |
| Not completed | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
Postoperative consumption of morphine equivalents
| morphine milligram equivalents | IV Lidocaine | Placebo |
|---|---|---|
| Hour 24 | 20.4 ± 8.0 | 9.1 ± 5.4 |
| Hour 48 | 22.5 ± 15.0 | 8.2 ± 14.1 |
Visual Analogue Scale pain score 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).
| score on a scale | IV Lidocaine | Placebo |
|---|---|---|
| Incision Pain Hour 6 Postoperative | 3.9 ± 3.0 | 3.3 ± 3.3 |
| Incision Pain Postoperative Day 1 | 5.3 ± 3.5 | 5.9 ± 4.0 |
| Incision Pain Postoperative Day 2 | 5.6 ± 2.6 | 4.2 ± 3.3 |
| Incision Pain Postoperative Day 3 | 6.3 ± 2.3 | 5.0 ± 1.4 |
| Incision Pain Postoperative Day 4 | 3.0 ± 2.8 | — |
| Incision Pain Postoperative Day 5 | 1.5 ± 2.1 | — |
| Incision Pain Week 2 | 1.6 ± 2.1 | 1.6 ± 3.7 |
| Incision Pain Week 6 | 0.8 ± 1.4 | 0 ± 0 |
| Incision Pain Month 6 | 0.3 ± 0.7 | 0 ± 0 |
| Shoulder Pain Hour 6 Postoperative | 5.0 ± 3.7 | 3.1 ± 3.2 |
| Shoulder Pain Postoperative Day 1 | 4.8 ± 4.0 | 1.9 ± 2.0 |
| Shoulder Pain Postoperative Day 2 | 4.4 ± 3.7 | 1.3 ± 1.5 |
| Shoulder Pain Postoperative Day 3 | 3.3 ± 3.2 | 1.5 ± 2.1 |
| Shoulder Pain Postoperative Day 4 | 1.0 ± 1.4 | — |
| Shoulder Pain Postoperative Day 5 | 0 ± 0 | — |
| Postoperative Week 2 | 0.6 ± 1.2 | 0 ± 0 |
| Postoperative Week 6 | 0.7 ± 1.3 | 0 ± 0 |
| Postoperative Month 6 | 0.3 ± 0.7 | 0 ± 0 |
Length of postoperative stay
| days | IV Lidocaine | Placebo |
|---|---|---|
| Length of Stay | 3.6 ± 1.9 | 3.1 ± 0.7 |
We will track when each patient passes first bowel movement
| days | IV Lidocaine | Placebo |
|---|---|---|
| Return of Bowel Function | 2.5 ± 1.0 | 1.8 ± 0.5 |
Number of hours until patient tolerates a normal diet
| hours | IV Lidocaine | Placebo |
|---|---|---|
| Hours to Toleration of Diet | 24.0 ± 6.3 | 22.3 ± 2.3 |
Collected over baseline to six months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IV Lidocaine | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Placebo | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Age, Continuous(years) | IV Lidocaine | Placebo | Total |
|---|---|---|---|
| Mean | 69.6 ± 6.7 | 72.1 ± 5.6 | 70.8 ± 6.2 |
| Sex: Female, Male(Participants) | IV Lidocaine | Placebo | Total |
|---|---|---|---|
| Female | 8 | 6 | 14 |
| Male | 0 | 1 | 1 |
| Ethnicity (NIH/OMB)(Participants) | IV Lidocaine | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 0 | 0 | 0 |
| Unknown or Not Reported | 8 | 7 | 15 |
| Race (NIH/OMB)(Participants) | IV Lidocaine | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 7 | 7 | 14 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
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Wake Forest University Health Sciences