Anesthesia Protocols for Hiatal Hernia Surgery

Recruiting in Palo Alto (17 mi)

Overseen by Steven Greenberg, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Endeavor Health

No Placebo Group

Trial Summary

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 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. ^{1 2 3 4 5}

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. ^{1 2 4 6 7}

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. ^{2 3 8 9 10}

Eligibility Criteria

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

I am between 18 and 90 years old and will have laparoscopic surgery for a hiatal hernia.

I am choosing to have keyhole surgery to fix my hiatal hernia.

Exclusion Criteria

I am having hiatal hernia surgery without using a camera.

I am undergoing urgent surgery for a hiatal hernia.

Patients with adverse reactions (e.g., anaphylaxis, rash) to any of the drugs in the OBA or OSA protocols.

Treatment Details

Interventions

• Opioid Based Anesthesia Protocol (OBA) (Other)
• Opioid Sparing Anesthesia Protocol (OSA) (Other)

Trial Overview The study compares two anesthesia methods during hiatal hernia surgery: an opioid sparing protocol (OSA) and a traditional opioid based one (OBA). The goal is to see if OSA reduces opioid use after surgery while maintaining pain control and satisfaction.

Participant Groups

Group I: Opioid Sparing Anesthesia Protocol Experimental Treatment 1 Intervention

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 II: Opioid Based Anesthesia Protocol Experimental Treatment 1 Intervention

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 (OBA) is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Opioid-Based Anesthesia Protocol for:

• General anesthesia for surgical procedures including laparoscopic hiatal hernia repair

🇪🇺 Approved in European Union as Opioid-Based Anesthesia Protocol for:

• General anesthesia for surgical procedures including laparoscopic hiatal hernia repair

🇨🇦 Approved in Canada as Opioid-Based Anesthesia Protocol for:

• General anesthesia for surgical procedures including laparoscopic hiatal hernia repair

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

NorthShore University HealthSystem Evanston, IL

Who Is Running the Clinical Trial?

Endeavor Health Lead Sponsor

NorthShore University HealthSystem Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

The Performance of Opioid-Free Anesthesia for Bariatric Surgery in Clinical Practice. [2023] Opioid-free anesthesia (OFA) is an alternative to conventional opioid-based anesthesia (OBA) in patients undergoing bariatric surgery. Several small studies and a meta-analysis have suggested advantages of OFA for bariatric surgery, but current evidence is still contradictory, and a universally accepted concept has not yet been established. The purpose of this study was to determine whether patients undergoing bariatric surgery experience less postoperative pain and better postoperative recovery when anesthetized with an OFA regimen than with an OBA regimen.

2. Spain pubmed.ncbi.nlm.nih.gov

[Impact of opioid free anaesthesia in bariatric surgery]. [2021] Patients subjected to bariatric surgery present a greater risk of complications due to the use of opioids. The goal is to evaluate the security and suitability of the Opioid Free Anaesthesia (OFA) protocol implemented in the Hospital Universitario Virgen de la Victoria in 2018.

3. Switzerland pubmed.ncbi.nlm.nih.gov

Lessons from the Analysis of a Retrospective Cohort of Patients Who Underwent Large Open Abdominal Surgery Under Total Intravenous Opioid-Free Anesthesia. [2021] Opioid-free anesthesia (OFA) is a new method of anesthesia based on a paradigm shift. Under general anesthesia, the physiology and/or the pathophysiological variations clinically observed are more a reflection of a systemic reaction to the stress (surgical and anesthesia stresses) than a true reflection of pain.

4. Switzerland pubmed.ncbi.nlm.nih.gov

Opioid-free anesthesia reduces the severity of acute postoperative motion-induced pain and patient-controlled epidural analgesia-related adverse events in lung surgery: randomized clinical trial. [2023] Opioids have been used as pain relievers for thousands of years. However, they may also cause undesirable side effects. We therefore performed this study to compare the effect of opioid-free anesthesia (OFA) versus opioid-sparing anesthesia (OSA) on postoperative pain and patient-controlled epidural analgesia (PCEA)-related events.

5. United States pubmed.ncbi.nlm.nih.gov

Effects of opioid-free anesthesia on postoperative morphine consumption after bariatric surgery. [2023] The objective of this study was to determine whether postoperative morphine requirement in obese patients undergoing laparoscopic bariatric surgery was reduced by opioid-free anesthesia (OFA), as compared to an anesthetic strategy using opioids (opioid balanced anesthesia (OBA)) and to investigate the differences that may exist between the use of clonidine and dexmedetomidine in the context of OFA.

6. Switzerland pubmed.ncbi.nlm.nih.gov

Opioid Reduced Anesthesia in Major Oncologic Cervicofacial Surgery: A Retrospective Study. [2023] Opioid sparing is one of the new challenges in anesthesia and perioperative medicine. Opioid reduced anesthesia (ORA) is part of this approach, and it consists of a multimodal analgesia-associating non-opioid analgesic regional anesthesia to reduce intraoperative opioid requirements. Major cervicofacial oncologic surgery could specifically benefit from ORA, since it is known to generate intense and prolonged postoperative pain, with a high risk of pulmonary complications.

7. North Macedonia pubmed.ncbi.nlm.nih.gov

Is Opioid-Free General Anesthesia More Superior for Postoperative Pain Versus Opioid General Anesthesia in Laparoscopic Cholecystectomy? [2022] Opioid-free anesthesia (OFA) is a new anesthesiological technique, where the giving of opioids (fentanyl) is avoided in the intra- and post-operative period. This leads to reduction in the opioid-related side effects and lower pain scores in the postoperative period.

8. Germany pubmed.ncbi.nlm.nih.gov

Effectiveness of Bariatric Surgery Targeting Opioid Prescriptions (BSTOP) protocol on postoperative pain control. [2023] Surgical pain management is a critical component in the success of bariatric procedures. With the opioid epidemic, there have been increased efforts to decrease opioid use. In 2019, the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program developed the BSTOP protocol, a multimodal perioperative pain management regimen to minimize opioid use. The objective of this study is to evaluate the effectiveness of the BSTOP protocol on patients' need for opioid medications during their perioperative care.

9. United States pubmed.ncbi.nlm.nih.gov

An Opioid Sparing Anesthesia Protocol for Pediatric Open Inguinal Hernia Repair: A Quality Improvement Project. [2022] Using plan-do-study-act (PDSA) cycles, this quality improvement (QI) project aimed to standardize an anesthetic protocol to optimize multimodal pain management for pediatric open inguinal hernia repair (OIHR).

10. China pubmed.ncbi.nlm.nih.gov

Multimodal analgesia model to achieve low postoperative opioid requirement following bariatric surgery. [2022] To investigate whether a new anaesthesia protocol can reduce opioid use in obese patients following laparoscopic sleeve gastrectomy.