Reducing Postoperative Opioids in Patients Undergoing Laparoscopic Hiatal Hernia

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: t
View:

• Patients from 18-90 years old who are undergoing laparoscopic hiatal hernia surgery

• Elective Laparoscopic hiatal hernia repair

Locations
United States
Illinois
Endeavor Health
RECRUITING
Evanston
Contact Information
Primary
Steven Greenberg, MD
sgreenberg@northshore.org
847-570-2760
Time Frame
Start Date: 2023-11-14
Estimated Completion Date: 2026-02-01
Participants
Target number of participants: 75
Treatments
Experimental: Opioid Sparing Anesthesia Protocol
The OSA protocol will include boluses of dexmedetomidine and ketamine at anesthesia induction, followed by a ketamine infusion that will continue until PACU discharge. Another bolus of ketamine will be administered upon surgical incision and another dexmedetomidine bolus will be given at surgical closure to reduce the use of opioids.
Other: Opioid Based Anesthesia Protocol
The OBA group will be administered a saline infusion at the same rate of the ketamine infusion (only while in the PACU) up until PACU discharge so that surgeons, patients, and PACU nurses will be blinded. The OBA group will be administered fentanyl 100 mcg IV for anesthesia induction followed by 50 mcg IV boluses when heart rate or systolic blood pressure is 20% above baseline throughout the case.
Sponsors
Leads: Endeavor Health

This content was sourced from clinicaltrials.gov