Clinical trial NCT05953428: Reducing Postoperative Opioids in Patients Undergoing Laparoscopic Hiatal Hernia
Official title: Reducing Postoperative Opioids in Patients Undergoing Laparoscopic Hiatal Hernia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hiatal Hernia
Keywords: Opioid Sparing Anesthesia Protocol
Opioid Based Anesthesia Protocol
Lead sponsor: Endeavor Health
Sponsor class: OTHER
First posted: 2023-07-20
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients undergoing laparoscopic hiatal hernia repairs will be randomized to:

Experimental Group: Opioid Sparing Anesthesia Protocol vs. Control Group: Opioid Based Anesthesia Protocol
Primary purpose: OTHER

Brief 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.

Detailed description: The administration of perioperative opioids to nearly 80% of surgical patients leaves approximately 6 million Americans susceptible to becoming opioid-dependent. This practice has been hypothesized as a contributing factor to the ongoing opioid crisis, where currently more than 136 Americans die from an opioid overdose every day. Recent data suggest a potential benefit of reducing perioperative opioid use, while improving the quality of surgical recovery when employing an Opioid Sparing Anesthesia (OSA) protocol with non-narcotic analgesics.

More than a million hernia repairs are performed each year in the US. With the significant nationwide obesity epidemic, it is estimated that the prevalence of hiatal hernias in the western population is approximately 20%. The investigators perform hundreds of laparoscopic hiatal hernia repairs annually at NorthShore University HealthSystem. Patients routinely receive fentanyl and other opioids during this surgery to reduce pain, but opioids also increase the risk of nausea, vomiting, and ileus. In addition, these patients are often times prescribed opioids upon discharge from the hospital. Preliminary results from a small, retrospective study among laparoscopic hiatal hernia surgical patients suggested that an OSA protocol with non-narcotic analgesics (that included dexmedetomidine and ketamine) resulted in a 33% reduction in those patients requiring opioids post-discharge. Moreover, these same patients had a significant reduction in hospital length of stay and nausea/retching. Therefore, the investigators propose a double-blinded randomized controlled trial to compare the number of patients in OSA protocol vs. Opioid Based Anesthesia (OBA) protocol groups, who require no opioids within 7 days postoperatively, (a time period where our quality data suggest nearly all patients receive postoperative opioids in this population).

Eligibility criteria: Inclusion Criteria:

* Patients from 18-90 years old who are undergoing laparoscopic hiatal hernia surgery
* Elective Laparoscopic hiatal hernia repair

Exclusion Criteria:

* Patients receiving urgent or emergent hiatal hernia surgery
* Patients receiving hiatal hernia surgery without laparoscopy
* Patients with adverse reactions (e.g., anaphylaxis, rash) to any of the drugs in the OBA or OSA protocols.

Primary outcomes:
measure: The difference in discharge opioid consumption in morphine milligram equivalents (MMEs)
timeFrame: through postoperative Day 7
Secondary outcomes:
measure: Postoperative Visual Analogue Scale (VAS) pain scores
timeFrame: Upon post-anesthesia care unit arrival (within 2 hours after surgery), upon post-anesthesia care unit discharge (4 hours after surgery), and upon hospital discharge (up to 7 days)
measure: Total Hospital Opioid Consumption (MMEs)
timeFrame: up to 7 days
measure: Post Anesthesia Care Unit
timeFrame: up to 7 days
measure: Hospital Length of stay
timeFrame: up to 7 days
measure: Incidence of post operative nausea and vomiting (PONV )
timeFrame: during post anesthesia care unit stay (up to 3 hours), postoperative Day 1, during hospital stay (up to 7 days)
measure: Rate of rehospitalization
timeFrame: within 30 days
measure: Rate of reoperation
timeFrame: within 30 days
measure: Rate of emergency room visit
timeFrame: within 30 days
measure: Surgeon satisfaction with surgical conditions
timeFrame: within 30 minutes after surgery
measure: Hospital Cost Differential
timeFrame: up to 30 days
Other outcomes:
Locations:
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
Study officials:
affiliation: Endeavor Health
name: Steven Greenberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Wengritzky R, Mettho T, Myles PS, Burke J, Kakos A. Development and validation of a postoperative nausea and vomiting intensity scale. Br J Anaesth. 2010 Feb;104(2):158-66. doi: 10.1093/bja/aep370. Epub 2009 Dec 26.