CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 16 enrolled / 16 target
Drug / intervention
IV lidocaine +1 moredrug
Likely dose
IV lidocaine 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04096170
NCT04096170Phase 4CompletedOn Track (0.2/mo)Completion was 26mo ago

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

Wake Forest University Health Sciences·interventional·Posted Sep 19, 2019·Updated Jun 23, 2026

In Brief

A Phase 4 clinical trial evaluating IV lidocaine and Placebo for Hernia, Paraesophageal. Completed, enrolled 16 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedSep 19, 2019
Enrollment StartJun 21, 2018
Primary CompletionApr 24, 2024
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 6.8 years ago

Arms & Interventions

IV Lidocaineexperimental

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
Placeboplacebo_comparator

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

Drug: Placebo

Interventions

IV lidocainedrug

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.

Placebodrug

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.