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

Who is this study for? Patients undergoing paraesophageal hernia repair
What treatments are being studied? Lidocaine
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
United States
North Carolina
Atrium Health - Carolinas Medical Center
RECRUITING
Charlotte
Contact Information
Primary
Greg Scarola
gregory.scarola@atriumhealth.org
704-355-5379
Time Frame
Start Date: 2018-06-21
Estimated Completion Date: 2026-01
Participants
Target number of participants: 50
Treatments
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.
Sponsors
Leads: Wake Forest University Health Sciences

This content was sourced from clinicaltrials.gov