Reducing Postoperative Opioids in Patients Undergoing Laparoscopic Hiatal Hernia

NCT ID: NCT05953428

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-14
• Study Completion Date: 2026-02-01

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).

Conditions

Hiatal Hernia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Opioid Sparing Anesthesia Protocol (OSA)

Intervention Type: OTHER

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.

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.

Group Type: OTHER

Opioid Based Anesthesia Protocol (OBA)

Intervention Type: OTHER

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.

Interventions

Opioid Sparing Anesthesia Protocol (OSA)

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.

Intervention Type: OTHER

Opioid Based Anesthesia Protocol (OBA)

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Endeavor Health

OTHER

Sponsor Role: lead

Responsible Party

Steven Greenberg

Jeffery S. Vender Endowed Chair of Anesthesiology Research and Education

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven Greenberg, MD

Role: PRINCIPAL_INVESTIGATOR

Endeavor Health

Locations

Endeavor Health

Evanston, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Steven Greenberg, MD

Role: CONTACT

sgreenberg@northshore.org

847-570-2760

Facility Contacts

Steven Greenberg, MD

Role: primary

sgreenberg@northshore.org

8475702760

References

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Reference Type: BACKGROUND

PMID: 32584407 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 33569727 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 32004171 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 25925031 (View on PubMed)

Hoffman C, Buddha M, Mai M, Sanjeevi S, Gutierrez R, O' Neill C, Miller A, Banki F. Opioid-Free Anesthesia and Same-Day Surgery Laparoscopic Hiatal Hernia Repair. J Am Coll Surg. 2022 Jul 1;235(1):86-98. doi: 10.1097/XCS.0000000000000229. Epub 2022 Apr 11.

Reference Type: BACKGROUND

PMID: 35703966 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 11369161 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20037151 (View on PubMed)

Other Identifiers

EH23-020

Identifier Type: -

Identifier Source: org_study_id