Hiatal HerniaNCT05953428
Reducing Postoperative Opioids in Patients Undergoing Laparoscopic Hiatal Hernia
A study testing Opioid Sparing Anesthesia Protocol (OSA) and Opioid Based Anesthesia Protocol (OBA) in people with Hiatal Hernia, run by Endeavor Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Hiatal Hernia
- What is being tested?
- Opioid Sparing Anesthesia Protocol (OSA) and Opioid Based Anesthesia Protocol (OBA)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2024to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients from 18-90 years old who are undergoing laparoscopic hiatal hernia surgery
- Elective Laparoscopic hiatal hernia repair
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Hiatal Hernia
- Being tested
- Opioid Sparing Anesthesia Protocol (OSA), Opioid Based Anesthesia Protocol (OBA)
- Keywords
- Opioid Sparing Anesthesia Protocol, Opioid Based Anesthesia Protocol
- Medical subject headings
- Hernia, Hiatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid Sparing Anesthesia Protocol (OSA)Other
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.
Opioid Based Anesthesia Protocol (OBA)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Opioid Sparing Anesthesia Protocol | Experimental | 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. Receives: Other: Opioid Sparing Anesthesia Protocol (OSA) |
| Opioid Based Anesthesia Protocol | Other | 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. Receives: Other: Opioid Based Anesthesia Protocol (OBA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Difference in Discharge Opioid Consumption in Morphine Milligram Equivalents (MMEs)
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.
Measured: Postoperative day 1,2, 3, 4, 5, 6 and 7.
Secondary outcomes (11)
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 cm. Number "0" indicates no pain and number "10" indicates terrible pain.
Measured: 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.
Postoperative Hospital Opioid Consumption (MMEs)
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.
Measured: From PACU admission until hospital discharge, up to 7 days after admission
Post Anesthesia Care Unit
Post anesthesia care unit (PACU) length of stay (hours) in each group will be recorded.
Measured: from PACU admission until PACU discharge
Hospital Length of Stay
Hospital length of stay (hours) in each group will be recorded.
Measured: from hospital admission for hernia surgery until hospital discharge
Incidence of Post Operative Nausea and Vomiting (PONV )
Incidence of post operative nausea and vomiting in each group will be recorded.
Measured: during post anesthesia care unit stay (up to 3 hours), postoperative Day 1, during hospital stay (up to 7 days)
Rate of Rehospitalization
Rate of rehospitalization will be recorded for each group up to 30 days after hiatal hernia surgery.
Measured: within 30 days of surgery
Rate of Reoperation
Rate of reoperation will be recorded for each group up to 30 days after hiatal hernia surgery.
Measured: within 30 days of surgery
Rate of Emergency Room Visit
Rate of emergency room visits will be recorded up to 30 days after hiatal hernia surgery.
Measured: within 30 days of surgery
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)
Measured: within 30 minutes after surgery
VAS Pain Severity Postoperative Days 1-7
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.
Measured: Postoperative days 1, 2, 3, 4, 5, 6, 7.
Total Ketorolac Dose
Total Ketorolac dose administered intraoperatively and postoperatively until hospital discharge
Measured: From hospital admission until hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start3 Mar 2024
- Primary completion23 Jan 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Hiatal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Greenberg, Endeavor Health
- Investigators
- Steven Greenberg, MD, Principal investigator, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05953428
- Sponsor's protocol ID
- EH23-020
- Status last verified
- Aug 2026
- First submitted
- 5 Jul 2023
- Last updated
- 13 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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/jamanetworkopen.2020.7367.
PubMed 32584407Bastawrous 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/s00464-021-08338-9. Epub 2021 Feb 10.
PubMed 33569727Siu 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.
PubMed 32004171Bakan 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. Braz J Anesthesiol. 2015 May-Jun;65(3):191-9. doi: 10.1016/j.bjane.2014.05.001. Epub 2014 Jun 3.
PubMed 25925031Hoffman 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.
PubMed 35703966Anderson 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.
PubMed 11369161Wengritzky 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.
PubMed 20037151
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Postoperative Opioids in Patients Undergoing Laparoscopic Hiatal Hernia
- ClinicalTrials.gov ID
- NCT05953428
- Acronym / sponsor ID
- EH23-020
- Conditions
- Hiatal Hernia
- Keywords
- Opioid Sparing Anesthesia Protocol, Opioid Based Anesthesia Protocol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Study start
- 3 Mar 2024 (actual)
- Primary completion
- 23 Jan 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 20 Jul 2023 (actual)
- Results
- Posted 13 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Opioid Sparing Anesthesia Protocol | Experimental | Other: Opioid Sparing Anesthesia Protocol (OSA)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. |
| Opioid Based Anesthesia Protocol | Other | Other: Opioid 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients from 18-90 years old who are undergoing laparoscopic hiatal hernia surgery
- Elective Laparoscopic hiatal hernia repair
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opioid 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. | Other | Opioid Sparing Anesthesia Protocol |
| Opioid 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. | Other | Opioid Based Anesthesia Protocol |
Primary outcome
The Difference in Discharge Opioid Consumption in Morphine Milligram Equivalents (MMEs)
Time frame: 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.
11 secondary outcomes
Postoperative Visual Analogue Scale (VAS) Pain Scores
Time frame: 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.
Postoperative Hospital Opioid Consumption (MMEs)
Time frame: From PACU admission until hospital discharge, up to 7 days after admission
Post Anesthesia Care Unit
Time frame: from PACU admission until PACU discharge
Hospital Length of Stay
Time frame: from hospital admission for hernia surgery until hospital discharge
Incidence of Post Operative Nausea and Vomiting (PONV )
Time frame: during post anesthesia care unit stay (up to 3 hours), postoperative Day 1, during hospital stay (up to 7 days)
Rate of Rehospitalization
Time frame: within 30 days of surgery
Rate of Reoperation
Time frame: within 30 days of surgery
Rate of Emergency Room Visit
Time frame: within 30 days of surgery
Surgeon Satisfaction With Surgical Conditions
Time frame: within 30 minutes after surgery
VAS Pain Severity Postoperative Days 1-7
Time frame: Postoperative days 1, 2, 3, 4, 5, 6, 7.
Total Ketorolac Dose
Time frame: From hospital admission until hospital discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32584407Lawal 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/jamanetworkopen.2020.7367.
- Background: PubMed 33569727Bastawrous 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/s00464-021-08338-9. Epub 2021 Feb 10.
- Background: PubMed 32004171Siu 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.
- Background: PubMed 25925031Bakan 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. Braz J Anesthesiol. 2015 May-Jun;65(3):191-9. doi: 10.1016/j.bjane.2014.05.001. Epub 2014 Jun 3.
- Background: PubMed 35703966Hoffman 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.
- Background: PubMed 11369161Anderson 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.
- Background: PubMed 20037151Wengritzky 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.
- Individual participant dataSharing planned: No
Related trials for Hiatal Hernia
Recruiting
GORE® ENFORM Biomaterial Product Study
Hernia, Ventral, Hernia, Hiatal
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD
Active, not recruiting
Gastropexy in the Repair of Patients With Paraesophageal Hernias
Paraesophageal Hernia
Recruiting
Phrenoesophageal Ligament Reconstruction With Mesh
Hiatus Hernia, Gastreoesophageal Reflux Disease
RecruitingObservational study
Preoperative Predictors of Symptom Improvement After Laparoscopic Fundoplication
Gastroesophageal Reflux Disease, Hiatal Hernia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Greenberg, MD principal investigator
Endeavor Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opioid Sparing Anesthesia Protocol (OSA) and Opioid Based Anesthesia Protocol (OBA) in people with Hiatal Hernia, run by Endeavor Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Difference in Discharge Opioid Consumption in Morphine Milligram Equivalents (MMEs) (time frame: Postoperative day 1,2, 3, 4, 5, 6 and 7.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05953428, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.