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

Conditions

• Hernia, Paraesophageal

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

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.
• 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.

Study Details

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.

Key Dates

Start date

Jun 21, 2018

Status verified

Feb 2026

Primary completion

May 31, 2026

Completion

May 31, 2026

Study Design

Enrollment

50 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.
• Placebo Comparator: Placebo
  Patients will receive D5W solution at the same volume and rate as the IV lidocaine.

Primary Outcome Measure

Post-Op Morphine Equivalents [ Time Frame: Post-operation up to 6 months ]

Central Contacts

• Greg Scarola
  704-355-5379
  [email protected]

Locations (1)

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