Reducing Postoperative Opioids in Patients Undergoing Laparoscopic Hiatal Hernia

NCT05953428 | Completed

• 1 other identifier: EH23-020
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hiatal Hernia

Keywords

Opioid Sparing Anesthesia Protocol; Opioid Based Anesthesia Protocol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Postoperative Visual Analogue Scale (VAS) pain scores

  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)

  up to 7 days

• Post Anesthesia Care Unit

  up to 7 days

• Hospital Length of stay

  up to 7 days

• Incidence of post operative nausea and vomiting (PONV )

  during post anesthesia care unit stay (up to 3 hours), postoperative Day 1, during hospital stay (up to 7 days)

Study Arms (2)

Opioid Sparing Anesthesia Protocol

EXPERIMENTAL

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)

Opioid Based Anesthesia Protocol

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.

Other: Opioid Based Anesthesia Protocol (OBA)

Interventions

Opioid Sparing Anesthesia Protocol (OSA) 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 Sparing Anesthesia Protocol

Opioid Based Anesthesia Protocol (OBA) 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.

Opioid Based Anesthesia Protocol

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Endeavor Health: lead

Study Sites (1)

Endeavor Health

Evanston, Illinois, 60201, United States

Location

Related Publications (7)

• Lawal OD, Gold J, Murthy A, Ruchi R, Bavry E, Hume AL, Lewkowitz AK, Brothers T, Wen X. Rate and Risk Factors Associated With Prolonged Opioid Use After Surgery: A Systematic Review and Meta-analysis. JAMA Netw Open. 2020 Jun 1;3(6):e207367. doi: 10.1001/jamanetworkopen.2020.7367.

  PMID: 32584407 RESULT

• Bastawrous AL, Brockhaus KK, Chang MI, Milky G, Shih IF, Li Y, Cleary RK. A national database propensity score-matched comparison of minimally invasive and open colectomy for long-term opioid use. Surg Endosc. 2022 Jan;36(1):701-710. doi: 10.1007/s00464-021-08338-9. Epub 2021 Feb 10.

  PMID: 33569727 RESULT

• Siu EY, Moon TS. Opioid-free and opioid-sparing anesthesia. Int Anesthesiol Clin. 2020 Spring;58(2):34-41. doi: 10.1097/AIA.0000000000000270. No abstract available.

  PMID: 32004171 RESULT

• Bakan M, Umutoglu T, Topuz U, Uysal H, Bayram M, Kadioglu H, Salihoglu Z. Opioid-free total intravenous anesthesia with propofol, dexmedetomidine and lidocaine infusions for laparoscopic cholecystectomy: a prospective, randomized, double-blinded study. Braz J Anesthesiol. 2015 May-Jun;65(3):191-9. doi: 10.1016/j.bjane.2014.05.001. Epub 2014 Jun 3.

  PMID: 25925031 RESULT

• 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.

  PMID: 35703966 RESULT

• Anderson R, Saiers JH, Abram S, Schlicht C. Accuracy in equianalgesic dosing. conversion dilemmas. J Pain Symptom Manage. 2001 May;21(5):397-406. doi: 10.1016/s0885-3924(01)00271-8.

  PMID: 11369161 RESULT

• 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.

  PMID: 20037151 RESULT

MeSH Terms

Conditions

Hernia, Hiatal

Condition Hierarchy (Ancestors)

Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Steven Greenberg, MD

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The study participants, surgeons and PACU nurses will be blinded.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jeffery S. Vender Endowed Chair of Anesthesiology Research and Education

Model Details: Patients undergoing laparoscopic hiatal hernia repairs will be randomized to: Experimental Group: Opioid Sparing Anesthesia Protocol vs. Control Group: Opioid Based Anesthesia Protocol

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: July 20, 2023
• Study Start: November 14, 2023
• Primary Completion: February 16, 2025
• Study Completion: April 30, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)