Anesthesia Protocols for Hiatal Hernia Surgery
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. Please consult with the trial coordinators for guidance.
What safety data exists for anesthesia protocols in hiatal hernia surgery?
The safety data for anesthesia protocols, including opioid-free and opioid-sparing approaches, suggest potential benefits in reducing postoperative pain and opioid-related side effects. Studies have shown that opioid-free anesthesia (OFA) can reduce the severity of postoperative pain and adverse events in various surgeries, such as lung and bariatric surgeries. Opioid-sparing anesthesia (OSA) and multimodal analgesia are also being explored to minimize opioid use and its associated risks. However, evidence is still evolving, and more research is needed to establish universally accepted protocols.12345
Is the Opioid Sparing Anesthesia Protocol (OSA) a promising treatment for hiatal hernia surgery?
Yes, the Opioid Sparing Anesthesia Protocol (OSA) is promising because it aims to reduce the use of opioids, which can lead to fewer complications and better pain management during and after surgery. This approach is part of a broader effort to minimize opioid use, which is important given the opioid epidemic. Studies have shown that similar protocols in other surgeries have been effective in managing pain while reducing the need for opioids.36789
What data supports the idea that Anesthesia Protocols for Hiatal Hernia Surgery is an effective treatment?
The available research shows that opioid-free anesthesia (OFA) can be effective in surgeries similar to hiatal hernia surgery, like bariatric and lung surgeries. For example, studies on bariatric surgery suggest that OFA may lead to less need for pain medication after surgery compared to traditional opioid-based anesthesia. Additionally, in lung surgery, OFA was found to reduce the severity of pain after surgery and decrease side effects related to pain management. These findings indicate that OFA could be a beneficial approach for managing pain and recovery in surgeries, potentially including hiatal hernia surgery.135610
Who Is on the Research Team?
Steven Greenberg, MD
Principal Investigator
Endeavor Health
Are You a Good Fit for This Trial?
This trial is for adults aged 18-90 scheduled for elective laparoscopic hiatal hernia repair surgery. It's not suitable for those needing urgent or non-laparoscopic surgery, or with allergies to drugs used in the anesthesia protocols.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo laparoscopic hiatal hernia repair surgery with either Opioid Sparing Anesthesia (OSA) or Opioid Based Anesthesia (OBA) protocol
Postoperative Monitoring
Participants are monitored for postoperative outcomes including opioid consumption, VAS pain scores, and incidence of nausea and vomiting
Follow-up
Participants are monitored for rehospitalization, reoperation, and emergency room visits
What Are the Treatments Tested in This Trial?
Interventions
- Opioid Based Anesthesia Protocol (OBA)
- Opioid Sparing Anesthesia Protocol (OSA)
Opioid Based Anesthesia Protocol (OBA) is already approved in United States, European Union, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Endeavor Health
Lead Sponsor
NorthShore University HealthSystem
Lead Sponsor