Hiatal Hernia Clinical Trial
Official title:
Reducing Postoperative Opioids in Patients Undergoing Laparoscopic Hiatal Hernia
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.
Status | Recruiting |
Enrollment | 75 |
Est. completion date | March 1, 2025 |
Est. primary completion date | January 1, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | NorthShore University HealthSystem | Evanston | Illinois |
Lead Sponsor | Collaborator |
---|---|
NorthShore University HealthSystem |
United States,
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. — View Citation
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. Br — View Citation
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/s00464-0 — View Citation
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 — View Citation
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/ — View Citation
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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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) | |
Secondary | Total Hospital Opioid Consumption (MMEs) | Total hospital opioid consumption (MMEs) in each group will be collected. | up to 7 days | |
Secondary | Post Anesthesia Care Unit | Post anesthesia care unit length of stay (hours) in each group will be recorded. | up to 7 days | |
Secondary | Hospital Length of stay | Hospital length of stay (days) in each group will be recorded. | up to 7 days | |
Secondary | 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) | |
Secondary | Rate of rehospitalization | Rate of rehospitalization will be recorded for each group up to 30 days after hiatal hernia surgery. | within 30 days | |
Secondary | Rate of reoperation | Rate of reoperation will be recorded for each group up to 30 days after hiatal hernia surgery. | within 30 days | |
Secondary | Rate of emergency room visit | Rate of emergency room visits will be recorded up to 30 days after hiatal hernia surgery. | within 30 days | |
Secondary | 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 | |
Secondary | Hospital Cost Differential | Hospital Cost Differential between groups while in hospital using direct operating cost. | up to 30 days |
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