Status:
RECRUITING
Improving Pain Control in Paraesophageal Hernia Repair: Intravenous Lidocaine Versus Placebo
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Hernia, Paraesophageal
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 w...
Detailed Description
Patients will be prospectively enrolled from Carolinas Hernia Center's outpatient clinic. All paraesophageal hernia patients, age 18 and older, undergoing PEH repair at CHS will be included. We will c...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Exclusion from all or portions will be at the discretion of the attending surgeon and anesthesiologist.
Key Trial Info
Start Date :
June 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04096170
Start Date
June 21 2018
End Date
January 1 2026
Last Update
January 29 2025
Active Locations (1)
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1
Atrium Health - Carolinas Medical Center
Charlotte, North Carolina, United States, 28203