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

NCT04096170 | Completed Phase 4 Results FDA Drug

• 3 other identifiers: IRB0008133206-18-03Pro00027862
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hernia, Paraesophageal

Outcome Measures

Primary Outcomes (5)

• Postoperative Morphine Equivalents

  Postoperative consumption of morphine equivalents

  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).

  post-op to 6 months

• Length of Stay

  Length of postoperative stay

  up to 1 week

• Return of Bowel Function

  We will track when each patient passes first bowel movement

  up to week 1

• Hours to Toleration of Diet

  Number of hours until patient tolerates a normal diet

  up to day 2

Study Arms (2)

IV Lidocaine

EXPERIMENTAL

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

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

IV lidocaine DRUG

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.

IV Lidocaine

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Atrium Health - Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

MeSH Terms

Conditions

Hernia, Hiatal

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Greg Scarola, MS, MBA
• Organization: Atrium Health

gregory.scarola@advocatehealth.org

704-355-5766

Study Officials

• Paul D Colavita, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 19, 2019
• Study Start: June 21, 2018
• Primary Completion: April 24, 2024
• Study Completion: April 24, 2024
• Last Updated: June 23, 2026
• Results First Posted: June 23, 2026

Record last verified: 2026-02

Locations

US (1)