Hiatal Hernia
Conditions
Keywords
Opioid Sparing Anesthesia Protocol, Opioid Based Anesthesia Protocol
Brief summary
This is a prospective randomized, double-blinded, controlled trial that will target enrollment of 46 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.
Detailed description
The administration of perioperative opioids to nearly 80% of surgical patients leaves approximately 6 million Americans susceptible to becoming opioid-dependent. This practice has been hypothesized as a contributing factor to the ongoing opioid crisis, where currently more than 136 Americans die from an opioid overdose every day. Recent data suggest a potential benefit of reducing perioperative opioid use, while improving the quality of surgical recovery when employing an Opioid Sparing Anesthesia (OSA) protocol with non-narcotic analgesics. More than a million hernia repairs are performed each year in the US. With the significant nationwide obesity epidemic, it is estimated that the prevalence of hiatal hernias in the western population is approximately 20%. The investigators perform hundreds of laparoscopic hiatal hernia repairs annually at NorthShore University HealthSystem. Patients routinely receive fentanyl and other opioids during this surgery to reduce pain, but opioids also increase the risk of nausea, vomiting, and ileus. In addition, these patients are often times prescribed opioids upon discharge from the hospital. Preliminary results from a small, retrospective study among laparoscopic hiatal hernia surgical patients suggested that an OSA protocol with non-narcotic analgesics (that included dexmedetomidine and ketamine) resulted in a 33% reduction in those patients requiring opioids post-discharge. Moreover, these same patients had a significant reduction in hospital length of stay and nausea/retching. Therefore, the investigators propose a double-blinded randomized controlled trial to compare the number of patients in OSA protocol vs. Opioid Based Anesthesia (OBA) protocol groups, who require no opioids within 7 days postoperatively, (a time period where our quality data suggest nearly all patients receive postoperative opioids in this population).
Interventions
OTHEROpioid Sparing Anesthesia Protocol (OSA)
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.
OTHEROpioid Based Anesthesia Protocol (OBA)
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.
Sponsors
Endeavor Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)
Masking description
The study participants, surgeons and PACU nurses will be blinded.
Intervention model description
Patients undergoing laparoscopic hiatal hernia repairs will be randomized to: Experimental Group: Opioid Sparing Anesthesia Protocol vs. Control Group: Opioid Based Anesthesia Protocol
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Difference in Discharge Opioid Consumption in Morphine Milligram Equivalents (MMEs) | Postoperative day 1,2, 3, 4, 5, 6 and 7. | The difference in discharge opioid consumption in morphine milligram equivalents (MMEs) from postoperative day 1 through postoperative day 7 in patients in the Opioid Sparing Anesthesia (OSA) protocol vs. Opioid Based Anesthesia (OBA) protocol will be collected. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Visual Analogue Scale (VAS) Pain Scores | Upon post-anesthesia care unit (PACU) arrival (within 2 hours after surgery), upon PACU discharge (4 hours after surgery), at hospital discharge, and on postoperative day 1, 2, 3, 4, 5, 6, and 7. | 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 cm. Number "0" indicates no pain and number "10" indicates terrible pain. |
| Postoperative Hospital Opioid Consumption (MMEs) | From PACU admission until hospital discharge, up to 7 days after admission | Total hospital opioid consumption (MMEs) in each group will be collected starting from the end of surgery (PACU admission) until hospital discharge or on postoperative day 7, whichever is first. |
| Post Anesthesia Care Unit | from PACU admission until PACU discharge | Post anesthesia care unit (PACU) length of stay (hours) in each group will be recorded. |
| Hospital Length of Stay | from hospital admission for hernia surgery until hospital discharge | Hospital length of stay (hours) in each group will be recorded. |
| 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) | Incidence of post operative nausea and vomiting in each group will be recorded. |
| Rate of Rehospitalization | within 30 days of surgery | Rate of rehospitalization will be recorded for each group up to 30 days after hiatal hernia surgery. |
| Rate of Reoperation | within 30 days of surgery | Rate of reoperation will be recorded for each group up to 30 days after hiatal hernia surgery. |
| Rate of Emergency Room Visit | within 30 days of surgery | Rate of emergency room visits will be recorded up to 30 days after hiatal hernia surgery. |
| Surgeon Satisfaction With Surgical Conditions | within 30 minutes after surgery | 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) |
| VAS Pain Severity Postoperative Days 1-7 | Postoperative days 1, 2, 3, 4, 5, 6, 7. | VAS Pain Severity was calculated for Postoperative Days 1-7. VAS scores of 0-3 were classified as mild, scores of 4-6 were classified as moderate, and scores of 7-10 were classified as severe. |
| Total Ketorolac Dose | From hospital admission until hospital discharge | Total Ketorolac dose administered intraoperatively and postoperatively until hospital discharge |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSteven Greenberg, MD
Endeavor Health
Participant flow
Recruitment details
This trial enrolled patients within the Endeavor Health Evanston, Glenbrook, and Highland Park Hospitals between March 2024 and January 2026. All participants provided written informed consent prior to their participation in the study via an electronic consent form in REDCap. Informed consent was obtained after receiving permission from the general surgery team to recruit the patient, followed by a discussion of the study and consent form with research staff via telephone.
Pre-assignment details
Two patients were withdrawn from the study following enrollment but prior to study group assignment. One patient was withdrawn prior to their surgery date because their procedure was scheduled at a hospital site not included in the original protocol. One patient was withdrawn due to a pharmacy drug error in which the study drug was not prepared correctly prior to their procedure.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 66 Years STANDARD_DEVIATION 9 |
| ASA Status 2 | 23 Participants |
| ASA Status 3 | 25 Participants |
| BMI | 28.7 kg/m² STANDARD_DEVIATION 4.7 |
| Height | 1.7 Meters STANDARD_DEVIATION 0.2 |
| History of Alcohol Use (Yes) | 7 Participants |
| History of Tobacco Use (Yes) | 6 Participants |
| Prescription Medications (Yes) | 22 Participants |
| Prior Abdominal Surgery (Yes) | 21 Participants |
| Race/Ethnicity, Customized Race Asian | 1 Participants |
| Race/Ethnicity, Customized Race Caucasian | 24 Participants |
| Race/Ethnicity, Customized Race Other/Unknown | 0 Participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 7 Participants |
| System Comorbidities (Yes) Cardiac (Yes) | 17 Participants |
| System Comorbidities (Yes) Endocrine (Yes) | 5 Participants |
| System Comorbidities (Yes) Kidney (Yes) | 0 Participants |
| System Comorbidities (Yes) Liver (Yes) | 1 Participants |
| System Comorbidities (Yes) Neurological (Yes) | 0 Participants |
| System Comorbidities (Yes) Respiratory (Yes) | 10 Participants |
| Weight | 91.0 Kilograms STANDARD_DEVIATION 19.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 25 |
| other Total, other adverse events | 2 / 23 | 1 / 25 |
| serious Total, serious adverse events | 2 / 23 | 1 / 25 |
Outcome results
None listed