Anesthesia Protocols for Hiatal Hernia Surgery

Overseen By Steven Greenberg, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Endeavor Health

Disqualifiers: Urgent surgery, Non-laparoscopic surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

75 Participants Needed

Trial Summary

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}

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.

Research Team

Steven Greenberg, MD

Principal Investigator

Endeavor Health

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 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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo laparoscopic hiatal hernia repair surgery with either Opioid Sparing Anesthesia (OSA) or Opioid Based Anesthesia (OBA) protocol

1 day

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for postoperative outcomes including opioid consumption, VAS pain scores, and incidence of nausea and vomiting

7 days

Daily monitoring (in-person or virtual)

Follow-up

Participants are monitored for rehospitalization, reoperation, and emergency room visits

30 days

Treatment Details

Interventions

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

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

Who Is Running the Clinical Trial?

Endeavor Health

Lead Sponsor

Trials

135

Recruited

742,000+

NorthShore University HealthSystem

Lead Sponsor

Trials

134

Recruited

740,000+

Findings from Research

In a study of 99 patients undergoing bariatric surgery, those who received opioid-free anesthesia (OFA) reported significantly less postoperative pain at both 24 and 48 hours compared to those who received opioid-based anesthesia (OBA).

Patients in the OFA group also experienced better overall recovery, as indicated by higher scores on the quality of recovery-40 questionnaire and lower postoperative opioid requirements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Performance of Opioid-Free Anesthesia for Bariatric Surgery in Clinical Practice. Ulbing, S., Infanger, L., Fleischmann, E., et al.[2023]

The Opioid Free Anaesthesia (OFA) protocol used in 38 patients undergoing laparoscopic bariatric surgery demonstrated effective pain control, with 68% of patients reporting no pain upon entering the Post Anaesthesia Care Unit.

The OFA protocol was found to be safe, with a high rate of successful hypertensive response control (88.1%) and low reliance on opioids, as only seven patients required a small dose of Pethidine post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Impact of opioid free anaesthesia in bariatric surgery]. Malo-Manso, A., Díaz-Crespo, J., Escalona-Belmonte, JJ., et al.[2021]

In a study of 311 patients undergoing major surgeries, a total intravenous opioid-free anesthesia (OFA) protocol was successfully implemented, resulting in minimal use of IV morphine (only 2 mg on average) during recovery, indicating effective pain management without opioids.

The findings suggest that OFA is a safe and feasible approach, as it effectively managed the physiological stress responses during surgery and required very low opioid consumption in the postoperative period, supporting a shift away from traditional opioid-based anesthesia.

NCBI (Pubmed)

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. Estebe, JP., Morel, M., Daouphars, T., et al.[2021]

In a study of 124 patients undergoing video-assisted lung surgery, opioid-free anesthesia (OFA) resulted in significantly lower pain severity during coughs on the first postoperative day compared to opioid-sparing anesthesia (OSA), with a VAS score of 1.88 versus 2.16.

The OFA group also experienced significantly fewer patient-controlled epidural analgesia (PCEA)-related adverse events, with only 19.6% of patients reporting issues compared to 47.3% in the OSA group.

NCBI (Pubmed)

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. Wang, S., Li, Y., Liang, C., et al.[2023]

In a study of 257 obese patients undergoing laparoscopic bariatric surgery, those who received opioid-free anesthesia (OFA) had a significantly higher rate of not requiring morphine in the first 24 hours post-surgery (87%) compared to those who received opioid balanced anesthesia (OBA) (52%).

Among the OFA patients, those who received dexmedetomidine (OFAD) were more successful in avoiding morphine (93%) compared to those who received clonidine (OFAC) (81%), indicating that dexmedetomidine may be a more effective option for reducing postoperative morphine consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of opioid-free anesthesia on postoperative morphine consumption after bariatric surgery. Berlier, J., Carabalona, JF., Tête, H., et al.[2023]

In a study of 172 patients undergoing major cervicofacial oncologic surgery, the opioid-reduced anesthesia (ORA) group required significantly less morphine (6.2 mg) compared to the standard opioid-based anesthesia group (10.1 mg), indicating a potential for reduced opioid consumption during surgery.

While ORA did not lead to lower postoperative pain scores or opioid requirements, it was associated with a reduced incidence of hypoxemia and the need for additional pressure-assisted ventilation, suggesting potential safety benefits that warrant further investigation in prospective studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opioid Reduced Anesthesia in Major Oncologic Cervicofacial Surgery: A Retrospective Study. Evrard, E., Motamed, C., Pagès, A., et al.[2023]

In a study of 60 patients undergoing elective laparoscopic cholecystectomy, opioid-free anesthesia (OFA) resulted in significantly lower pain scores and reduced opioid requirements compared to traditional anesthesia with fentanyl, particularly noted at 1 and 24 hours post-surgery.

The OFA group reported no severe pain (scores of 7-10 on the Visual Analogue Scale) at 24 hours after surgery, demonstrating that OFA is a safe and effective alternative that minimizes opioid-related side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is Opioid-Free General Anesthesia More Superior for Postoperative Pain Versus Opioid General Anesthesia in Laparoscopic Cholecystectomy? Toleska, M., Dimitrovski, A.[2022]

The BSTOP protocol, implemented in bariatric surgery patients, led to a significant 36% reduction in inpatient opioid use and a 57% reduction in outpatient opioid use, demonstrating its effectiveness in minimizing opioid consumption during recovery.

The study also found that the inclusion of gabapentin in the BSTOP protocol is essential, as its absence resulted in increased opioid use, highlighting its role in effective pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Bariatric Surgery Targeting Opioid Prescriptions (BSTOP) protocol on postoperative pain control. Seu, R., Pereira, X., Goriacko, P., et al.[2023]

The quality improvement project successfully implemented an opioid-sparing anesthetic protocol for pediatric open inguinal hernia repair, using ilioinguinal blocks and dexmedetomidine, which did not negatively impact postoperative pain scores or the rate of patients needing rescue morphine.

Over 641 surgeries conducted from July 2015 to June 2021, the new protocol led to a reduction in the percentage of patients requiring rescue morphine and improved anesthesia preparation duration, indicating enhanced efficiency and safety in pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Opioid Sparing Anesthesia Protocol for Pediatric Open Inguinal Hernia Repair: A Quality Improvement Project. Chiem, JL., Franz, A., Bishop, N., et al.[2022]

In a study of 30 obese patients undergoing laparoscopic sleeve gastrectomy, nearly half (46.7%) did not need any opioids for pain relief after surgery, indicating the effectiveness of the new anaesthesia protocol.

The use of multimodal analgesia, including local anaesthetic infiltration, significantly reduced the overall opioid requirement, with an average of only 32 mg of pethidine needed per patient, suggesting a safer approach to pain management in bariatric surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodal analgesia model to achieve low postoperative opioid requirement following bariatric surgery. Lam, KK., Mui, WL.[2022]

References

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

The Performance of Opioid-Free Anesthesia for Bariatric Surgery in Clinical Practice. [2023]

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

[Impact of opioid free anaesthesia in bariatric surgery]. [2021]

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]

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]

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

Effects of opioid-free anesthesia on postoperative morphine consumption after bariatric surgery. [2023]

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

Opioid Reduced Anesthesia in Major Oncologic Cervicofacial Surgery: A Retrospective Study. [2023]

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]

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

Effectiveness of Bariatric Surgery Targeting Opioid Prescriptions (BSTOP) protocol on postoperative pain control. [2023]

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

An Opioid Sparing Anesthesia Protocol for Pediatric Open Inguinal Hernia Repair: A Quality Improvement Project. [2022]

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

Multimodal analgesia model to achieve low postoperative opioid requirement following bariatric surgery. [2022]