Reducing Postoperative Opioids in Patients Undergoing Laparoscopic Hiatal Hernia

Study Overview
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Brief Summary
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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
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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).

Official Title
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Reducing Postoperative Opioids in Patients Undergoing Laparoscopic Hiatal Hernia

Conditions
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Hiatal Hernia

Intervention / Treatment
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* Other: Opioid Sparing Anesthesia Protocol (OSA)
* Other: Opioid Based Anesthesia Protocol (OBA)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Opioid Sparing Anesthesia Protocol<br>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 Sparing Anesthesia Protocol (OSA)<br>* 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.<br>|
| Other: Opioid Based Anesthesia Protocol<br>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. | Other: Opioid Based Anesthesia Protocol (OBA)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in discharge opioid consumption in morphine milligram equivalents (MMEs) | The difference in discharge opioid consumption in morphine milligram equivalents (MMEs) through postoperative day 7 in patients in the Opioid Sparing Anesthesia (OSA) protocol vs. Opioid Based Anesthesia (OBA) protocol will be collected. | through postoperative Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Visual Analogue Scale (VAS) pain scores | Patients Visual Analogue Scale (VAS) pain scores in each group will be collected. Subjects will rate their pain level on a scale of 0-10. Number 0 indicates no pain and number 10 indicates terrible pain. | 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) | 
| Total Hospital Opioid Consumption (MMEs) | Total hospital opioid consumption (MMEs) in each group will be collected. | up to 7 days | 
| Post Anesthesia Care Unit | Post anesthesia care unit length of stay (hours) in each group will be recorded. | up to 7 days | 
| Hospital Length of stay | Hospital length of stay (days) in each group will be recorded. | up to 7 days | 
| Incidence of post operative nausea and vomiting (PONV ) | Incidence of post operative nausea and vomiting in each group will be recorded. | during post anesthesia care unit stay (up to 3 hours), postoperative Day 1, during hospital stay (up to 7 days) | 
| Rate of rehospitalization | Rate of rehospitalization will be recorded for each group up to 30 days after hiatal hernia surgery. | within 30 days | 
| Rate of reoperation | Rate of reoperation will be recorded for each group up to 30 days after hiatal hernia surgery. | within 30 days | 
| Rate of emergency room visit | Rate of emergency room visits will be recorded up to 30 days after hiatal hernia surgery. | within 30 days | 
| Surgeon satisfaction with surgical conditions | Surgeon satisfaction with surgical conditions using a 5-point Likert score will be collected after surgery. A scale from 1-5; 1=Very dissatisfied, 2=Somewhat dissatisfied, 3=Neutral, 4=Somewhat satisfied, 5=Very satisfied) | within 30 minutes after surgery | 
| Hospital Cost Differential | Hospital Cost Differential between groups while in hospital using direct operating cost. | up to 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opioid Sparing Anesthesia Protocol, Opioid Based Anesthesia Protocol