RECRUITING

Reducing Postoperative Opioids in Patients Undergoing Laparoscopic Hiatal Hernia

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

This is a prospective randomized, double-blinded, controlled trial that will enroll 75 subjects undergoing laparoscopic hiatal hernia repair surgery. Participants who meet eligibility criteria will be randomized in a 1:1 ratio to receive either the opioid sparring anesthesia protocol (OSA) or the opioid based anesthesia protocol (OBA). The purpose of this study is to investigate if an opioid sparring protocol for laparoscopic hiatal hernia repair will reduce opioid consumption during discharge. Other outcomes include: postoperative VAS scores (PACU arrival, PACU discharge, hospital discharge), total in hospital opioid consumption, PACU length of stay, incidence of postoperative nausea and vomiting (PONV in PACU, postoperative day 1, during hospital stay), rehospitalization rate, rate of reoperation, rate of emergency room visit, surgeon satisfaction, and hospital cost differential.

Official Title

Reducing Postoperative Opioids in Patients Undergoing Laparoscopic Hiatal Hernia

Quick Facts

Study Start:2023-11-14
Study Completion:2025-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05953428

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 to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients from 18-90 years old who are undergoing laparoscopic hiatal hernia surgery
  2. * Elective Laparoscopic hiatal hernia repair
  1. * Patients receiving urgent or emergent hiatal hernia surgery
  2. * Patients receiving hiatal hernia surgery without laparoscopy
  3. * Patients with adverse reactions (e.g., anaphylaxis, rash) to any of the drugs in the OBA or OSA protocols.

Contacts and Locations

Study Contact

Steven Greenberg, MD
CONTACT
847-570-2760
sgreenberg@northshore.org

Principal Investigator

Steven Greenberg, MD
PRINCIPAL_INVESTIGATOR
NorthShore University HealthSystem

Study Locations (Sites)

NorthShore University HealthSystem
Evanston, Illinois, 60201
United States

Collaborators and Investigators

Sponsor: NorthShore University HealthSystem

  • Steven Greenberg, MD, PRINCIPAL_INVESTIGATOR, NorthShore University HealthSystem

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 Date2023-11-14
Study Completion Date2025-03-01

Study Record Updates

Study Start Date2023-11-14
Study Completion Date2025-03-01

Terms related to this study

Keywords Provided by Researchers

  • Opioid Sparing Anesthesia Protocol
  • Opioid Based Anesthesia Protocol

Additional Relevant MeSH Terms

  • Hiatal Hernia