RECRUITING

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

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2018-06-21

Study Completion:2025-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04096170

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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.	* 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.

Inclusion Criteria

Exclusion Criteria

* 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.

* 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.

Contacts and Locations

Study Contact

Greg Scarola

CONTACT

704-355-5379

gregory.scarola@atriumhealth.org

Principal Investigator

Paul D Colavita, MD

PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Study Locations (Sites)

Atrium Health - Carolinas Medical Center

Charlotte, North Carolina, 28203

United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

Paul D Colavita, MD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-06-21

Study Completion Date2025-07

Study Record Updates

Study Start Date2018-06-21

Study Completion Date2025-07

Terms related to this study

Additional Relevant MeSH Terms

Hernia, Paraesophageal