NCT04096170 (PEH) is a Phase 4 clinical trial of IV lidocaine in Hernia, Paraesophageal, sponsored by Wake Forest University Health Sciences.

Who is sponsoring NCT04096170?

NCT04096170 is sponsored by Wake Forest University Health Sciences.

What drugs are being tested in NCT04096170?

Interventions in NCT04096170: IV lidocaine, Placebo.

What condition does NCT04096170 study?

NCT04096170 studies Hernia, Paraesophageal.

Is NCT04096170 still recruiting?

NCT04096170 is currently recruiting now. Last updated 2 February 2026.

Last reviewed 2026-02-02 · How we verify

NCT04096170: PEH

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Recruiting now Phase 4 Last updated 2 February 2026

What this trial tests

Phase 4 trial testing IV lidocaine in Hernia, Paraesophageal in 50 participants. Currently enrolling.

Timeline

21 June 2018

Primary endpoint
1 May 2026

1 May 2026

Quick facts

Lead sponsor	Wake Forest University Health Sciences
Phase	Phase 4
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	50
Start date	21 June 2018
Primary completion	1 May 2026
Estimated completion	1 May 2026
Sites	1 location across United States

Drugs / interventions tested

IV lidocaine — full drug profile →
Placebo

Conditions studied

Hernia, Paraesophageal — all drugs for Hernia, Paraesophageal →

Sponsor

Wake Forest University Health Sciences

Who can join

18 and older, any sex, with Hernia, Paraesophageal. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Post-Op Morphine Equivalents
Time frame: Post-operation up to 6 months
Post-operative consumption of morphine equivalents
VAS Pain Score
Time frame: post-op to 6 months
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).
Length of Stay
Time frame: up to 6 months
Length of stay post op
Return of bowel function
Time frame: up to 6 months
We will track when each patient passes first bowel movement expressed as hours since operation
Day to toleration of diet
Time frame: up to 6 months
When the patient tolerates a normal diet

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of IV lidocaine

Trials testing the same drug.

NCT04505644 — Lidocaine Patch Versus Intravenous Lidocaine in Pain Relief After Cesarean Section · NA · unknown
NCT04506034 — Lidocaine Patch Versus Intravenous Lidocaine in Pain Relief After Laparoscopy · NA · unknown
NCT03893318 — IV Lidocaine in Pediatric AIS · Phase 4 · terminated

Other Wake Forest University Health Sciences trials

Trials by the same sponsor.

NCT07474090 — Personalized Exercise Program for Survivors of Breast Cancer, STEPS-BC Trial · NA · not yet recruiting
NCT07282444 — A New Way to Share Radiation Therapy Plans Between Doctors, CORRECT Trial · NA · not yet recruiting
NCT06876896 — Intra-abdominal Pressure (IAP) During PFA Treatment of A-fib/ A-Flutter · NA · recruiting
NCT07227051 — Optimizing Self-Monitoring Feedback Delivery for the Treatment of Overweight and Obesity · NA · recruiting
NCT07215624 — Surgical Thromboprophylaxis Practices in Oncology Patients Within the NCORP Network, STOP-VTE Study · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04096170 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Wake Forest University Health Sciences
Last refreshed: 2 February 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04096170.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing