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CompletedNCT04096170PEHUpdated Jun 23, 2026Results posted

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

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

Phase
Phase 4
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Hernia, Paraesophageal

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    IV Lidocaine

    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

  • Placebo comparator
    Placebo

    Patients will receive D5W solution at the same volume and rate as the IV lidocaine.

    Drug: Placebo

Interventions

  • DrugIV lidocaine

    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.

  • DrugPlacebo

    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.

05

What researchers measure

Primary outcomes

  1. Postoperative Morphine Equivalents

    Postoperative consumption of morphine equivalents

    Time frame: Post-operation up to 48 hours

  2. 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

  3. Length of Stay

    Length of postoperative stay

    Time frame: up to 1 week

  4. Return of Bowel Function

    We will track when each patient passes first bowel movement

    Time frame: up to week 1

  5. Hours to Toleration of Diet

    Number of hours until patient tolerates a normal diet

    Time frame: up to day 2

06

Results

Posted Jun 23, 2026

Participant flow

Participant flow — Overall Study
MilestoneIV LidocainePlacebo
Started88
Completed87
Not completed01
Withdrew: Withdrawal by subject01

Outcome measures

PrimaryPostoperative Morphine Equivalents

Postoperative consumption of morphine equivalents

Time frame:
Post-operation up to 48 hours
Reported as:
Mean · morphine milligram equivalents
Postoperative Morphine Equivalents
morphine milligram equivalentsIV LidocainePlacebo
Hour 2420.4 ± 8.09.1 ± 5.4
Hour 4822.5 ± 15.08.2 ± 14.1
PrimaryVisual 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
Reported as:
Mean · score on a scale
Visual Analogue Scale Pain Score
score on a scaleIV LidocainePlacebo
Incision Pain Hour 6 Postoperative3.9 ± 3.03.3 ± 3.3
Incision Pain Postoperative Day 15.3 ± 3.55.9 ± 4.0
Incision Pain Postoperative Day 25.6 ± 2.64.2 ± 3.3
Incision Pain Postoperative Day 36.3 ± 2.35.0 ± 1.4
Incision Pain Postoperative Day 43.0 ± 2.8—
Incision Pain Postoperative Day 51.5 ± 2.1—
Incision Pain Week 21.6 ± 2.11.6 ± 3.7
Incision Pain Week 60.8 ± 1.40 ± 0
Incision Pain Month 60.3 ± 0.70 ± 0
Shoulder Pain Hour 6 Postoperative5.0 ± 3.73.1 ± 3.2
Shoulder Pain Postoperative Day 14.8 ± 4.01.9 ± 2.0
Shoulder Pain Postoperative Day 24.4 ± 3.71.3 ± 1.5
Shoulder Pain Postoperative Day 33.3 ± 3.21.5 ± 2.1
Shoulder Pain Postoperative Day 41.0 ± 1.4—
Shoulder Pain Postoperative Day 50 ± 0—
Postoperative Week 20.6 ± 1.20 ± 0
Postoperative Week 60.7 ± 1.30 ± 0
Postoperative Month 60.3 ± 0.70 ± 0
PrimaryLength of Stay

Length of postoperative stay

Time frame:
up to 1 week
Reported as:
Mean · days
Length of Stay
daysIV LidocainePlacebo
Length of Stay3.6 ± 1.93.1 ± 0.7
PrimaryReturn of Bowel Function

We will track when each patient passes first bowel movement

Time frame:
up to week 1
Reported as:
Mean · days
Return of Bowel Function
daysIV LidocainePlacebo
Return of Bowel Function2.5 ± 1.01.8 ± 0.5
PrimaryHours to Toleration of Diet

Number of hours until patient tolerates a normal diet

Time frame:
up to day 2
Reported as:
Mean · hours
Hours to Toleration of Diet
hoursIV LidocainePlacebo
Hours to Toleration of Diet24.0 ± 6.322.3 ± 2.3

Adverse events

Collected over baseline to six months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
IV Lidocaine0/8 (0%)0/8 (0%)0/8 (0%)
Placebo0/7 (0%)0/7 (0%)0/7 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)IV LidocainePlaceboTotal
Mean69.6 ± 6.772.1 ± 5.670.8 ± 6.2
Sex: Female, Male
Sex: Female, Male(Participants)IV LidocainePlaceboTotal
Female8614
Male011
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)IV LidocainePlaceboTotal
Hispanic or Latino000
Not Hispanic or Latino000
Unknown or Not Reported8715
Race (NIH/OMB)
Race (NIH/OMB)(Participants)IV LidocainePlaceboTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American101
White7714
More than one race000
Unknown or Not Reported000
07

Study locations

1 site
  • Atrium Health - Carolinas Medical Center
    Charlotte, North Carolina 28203, United States
08

References and documents

Study documents

  • Protocol and statistical analysis plan · May 25, 2022
  • Informed consent form · Jan 21, 2026

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT04096170
Lead sponsor
Wake Forest University Health Sciences
Responsible party
Sponsor
First posted
Sep 19, 2019
Start date
Jun 21, 2018
Primary completion
Apr 24, 2024
Completion
Apr 24, 2024
Results posted
Jun 23, 2026
Last update
Jun 23, 2026

Study contacts

Paul D Colavita, MD
principal investigator · Wake Forest University Health Sciences

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
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