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New study tests IV lidocaine for easier hernia recovery

NCT ID NCT04096170

Symptom relief Sponsor: Wake Forest University Health Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether giving IV lidocaine during paraesophageal hernia surgery can reduce pain and speed recovery. About 50 adults having elective laparoscopic hernia repair will receive either lidocaine or a placebo alongside standard pain management. Researchers will measure pain scores, morphine use, hospital stay length, and return of bowel function.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

16 people

The number who actually took part.

Started

Jun 2018

Finished

Apr 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

hiatus hernia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hernia, paraesophageal

Contacts and locations

Locations

  • Atrium Health - Carolinas Medical Center

    Charlotte, North Carolina, 28203, United States