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CompletedNCT05953428Updated Nov 4, 2026Results posted

Reducing Postoperative Opioids in Patients Undergoing Laparoscopic Hiatal Hernia

An interventional study of Opioid Sparing Anesthesia Protocol (OSA) and Opioid Based Anesthesia Protocol (OBA) in Hiatal Hernia, sponsored by Endeavor Health. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Endeavor Health · Not applicable, Interventional, and Other

Updated Nov 4, 2026Posted results revisedPrimary outcomes revisedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

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).

02

Conditions studied

  • Hiatal Hernia

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Keywords

  • Opioid Sparing Anesthesia Protocol
  • Opioid Based Anesthesia Protocol
03

In context

Hernia, Hiatal

87 studies on the registry are indexed under Hernia, Hiatal; 27 are open to participants now.

This study's enrollment of 50 is below the median of 100 across 56 interventional studies indexed under Hernia, Hiatal.

Browse Hernia, Hiatal studies →

Lead sponsor

Endeavor Health is the lead sponsor of 111 studies on the registry; 34 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 9 (75%) have results posted.

Browse Endeavor Health studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients from 18-90 years old who are undergoing laparoscopic hiatal hernia surgery
  • Elective Laparoscopic hiatal hernia repair

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Opioid Sparing Anesthesia Protocol

    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.

    Other: Opioid Sparing Anesthesia Protocol (OSA)

  • Other
    Opioid Based Anesthesia Protocol

    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 (OBA)

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.

06

What researchers measure

Primary outcomes

  1. The Difference in Discharge Opioid Consumption in Morphine Milligram Equivalents (MMEs)

    Cumulative outpatient oral opioid consumption, expressed in morphine milligram equivalents (MMEs), from hospital discharge through postoperative day 7 was compared between the Opioid Sparing Anesthesia (OSA) and Opioid Based Anesthesia (OBA) groups.

    Time frame: From hospital discharge through postoperative day 7.

Secondary outcomes

  1. 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.

    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.

  2. 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.

    Time frame: From PACU admission until hospital discharge, up to 7 days after admission

  3. Post Anesthesia Care Unit

    Post anesthesia care unit (PACU) length of stay (hours) in each group will be recorded.

    Time frame: from PACU admission until PACU discharge

  4. Hospital Length of Stay

    Hospital length of stay (hours) in each group will be recorded.

    Time frame: from hospital admission for hernia surgery until hospital discharge

  5. Incidence of Post Operative Nausea and Vomiting (PONV )

    Incidence of post operative nausea and vomiting in each group will be recorded.

    Time frame: during post anesthesia care unit stay (up to 3 hours), postoperative Day 1, during hospital stay (up to 7 days)

  6. Rate of Rehospitalization

    Rate of rehospitalization will be recorded for each group up to 30 days after hiatal hernia surgery.

    Time frame: within 30 days of surgery

  7. Rate of Reoperation

    Rate of reoperation will be recorded for each group up to 30 days after hiatal hernia surgery.

    Time frame: within 30 days of surgery

  8. Rate of Emergency Room Visit

    Rate of emergency room visits will be recorded up to 30 days after hiatal hernia surgery.

    Time frame: within 30 days of surgery

  9. 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)

    Time frame: within 30 minutes after surgery

  10. 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.

    Time frame: Postoperative days 1, 2, 3, 4, 5, 6, 7.

  11. Total Ketorolac Dose

    Total Ketorolac dose administered intraoperatively and postoperatively until hospital discharge

    Time frame: From hospital admission until hospital discharge

07

Results

Posted Aug 13, 2026
Limitations and caveats
1. The study was conducted at a single hospital system 2. Enrollment was restricted to adult patients undergoing elective laparoscopic hiatal hernia repair surgery and excluded revision surgeries 3. A significant portion of data collection relied on participant self-reporting which could have inaccuracies 4. Subjects were not evaluated for side effects (nausea and vomiting, constipation, opioid dependence) after hospital discharge

Participant flow

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.

Participant flow — Overall Study
MilestoneOpioid Sparing Anesthesia ProtocolOpioid Based Anesthesia Protocol
Started2325
Completed2325
Not completed00

Outcome measures

PrimaryThe Difference in Discharge Opioid Consumption in Morphine Milligram Equivalents (MMEs)

Cumulative outpatient oral opioid consumption, expressed in morphine milligram equivalents (MMEs), from hospital discharge through postoperative day 7 was compared between the Opioid Sparing Anesthesia (OSA) and Opioid Based Anesthesia (OBA) groups.

Time frame:
From hospital discharge through postoperative day 7.
Reported as:
Median · MMEs
The Difference in Discharge Opioid Consumption in Morphine Milligram Equivalents (MMEs)
MMEsOpioid Sparing Anesthesia ProtocolOpioid Based Anesthesia Protocol
Postoperative Day 17.5 (0 to 10)0 (0 to 10)
Postoperative Day 27.5 (0 to 10)0 (0 to 8.75)
Postoperative Day 30 (0 to 10)0 (0 to 5.62)
Postoperative Day 40 (0 to 10)0 (0 to 0)
Postoperative Day 50 (0 to 7.5)0 (0 to 0)
Postoperative Day 60 (0 to 0)0 (0 to 0)
Postoperative Day 70 (0 to 0)0 (0 to 0)
Total Post-Discharge MME Consumption16 (0 to 61.25)0 (0 to 25)
Statistical analysis
  • Opioid Sparing Anesthesia Protocol vs Opioid Based Anesthesia Protocol · Wilcoxon (Mann-Whitney) · p = 0.0355
  • Opioid Sparing Anesthesia Protocol vs Opioid Based Anesthesia Protocol · Multiple imputation (MICE) · p = 0.0550 · Mean difference (final values): 18.80 · 95% CI -0.40 to 37.99OSA minus OBA; pooled across 500 multiply imputed datasets.
SecondaryPostoperative 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.

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.
Reported as:
Mean · cm
Postoperative Visual Analogue Scale (VAS) Pain Scores
cmOpioid Sparing Anesthesia ProtocolOpioid Based Anesthesia Protocol
PACU Admission3.7 ± 3.74.1 ± 3.4
PACU Discharge3.6 ± 1.63.5 ± 2.2
Hospital Discharge3.3 ± 2.13.0 ± 2.2
Postoperative Day 15.2 ± 2.05.6 ± 2.1
Postoperative Day 24.9 ± 1.95.1 ± 2.1
Postoperative Day 34.2 ± 2.14.5 ± 2.3
Postoperative Day 43.6 ± 2.63.2 ± 1.6
Postoperative Day 53.3 ± 2.62.9 ± 2.0
Postoperative Day 62.7 ± 2.62.0 ± 1.5
Postoperative Day 72.3 ± 2.61.9 ± 1.5
Statistical analysis
  • Opioid Sparing Anesthesia Protocol vs Opioid Based Anesthesia Protocol · Wilcoxon (Mann-Whitney) · p = 0.6522
  • Opioid Sparing Anesthesia Protocol vs Opioid Based Anesthesia Protocol · Wilcoxon (Mann-Whitney) · p = 0.9358
  • Opioid Sparing Anesthesia Protocol vs Opioid Based Anesthesia Protocol · Wilcoxon (Mann-Whitney) · p = 0.5425
  • Opioid Sparing Anesthesia Protocol vs Opioid Based Anesthesia Protocol · Wilcoxon (Mann-Whitney) · p = 0.5863
  • Opioid Sparing Anesthesia Protocol vs Opioid Based Anesthesia Protocol · Wilcoxon (Mann-Whitney) · p = 0.7474
  • Opioid Sparing Anesthesia Protocol vs Opioid Based Anesthesia Protocol · Wilcoxon (Mann-Whitney) · p = 0.6624
  • Opioid Sparing Anesthesia Protocol vs Opioid Based Anesthesia Protocol · Wilcoxon (Mann-Whitney) · p = 0.4429
  • Opioid Sparing Anesthesia Protocol vs Opioid Based Anesthesia Protocol · Wilcoxon (Mann-Whitney) · p = 0.5794
  • Opioid Sparing Anesthesia Protocol vs Opioid Based Anesthesia Protocol · Wilcoxon (Mann-Whitney) · p = 0.2842
  • Opioid Sparing Anesthesia Protocol vs Opioid Based Anesthesia Protocol · Wilcoxon (Mann-Whitney) · p = 0.4910
  • Opioid Sparing Anesthesia Protocol vs Opioid Based Anesthesia Protocol · Mixed Models Analysis · p = 0.375Global treatment-by-day interaction; P value calibrated with 4,999 parametric-bootstrap replicates.
SecondaryPostoperative 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.

Time frame:
From PACU admission until hospital discharge, up to 7 days after admission
Reported as:
Median · MMEs
Postoperative Hospital Opioid Consumption (MMEs)
MMEsOpioid Sparing Anesthesia ProtocolOpioid Based Anesthesia Protocol
PACU28 (4 to 40)25 (10 to 58)
Postoperative Day 10 (0 to 18)0 (0 to 0)
Postoperative Day 20 (0 to 0)0 (0 to 0)
Postoperative Day 30 (0 to 0)0 (0 to 0)
Postoperative Day 40 (0 to 0)0 (0 to 0)
Postoperative Day 50 (0 to 0)0 (0 to 0)
Postoperative Day 60 (0 to 0)0 (0 to 0)
Postoperative Day 70 (0 to 0)0 (0 to 0)
Total30 (8 to 66)40 (13 to 68)
Statistical analysis
  • Opioid Sparing Anesthesia Protocol vs Opioid Based Anesthesia Protocol · Wilcoxon (Mann-Whitney) · p = 0.6576
  • Opioid Sparing Anesthesia Protocol vs Opioid Based Anesthesia Protocol · Wilcoxon (Mann-Whitney) · p = 0.6749
  • Opioid Sparing Anesthesia Protocol vs Opioid Based Anesthesia Protocol · Wilcoxon (Mann-Whitney) · p = 0.6251
  • Opioid Sparing Anesthesia Protocol vs Opioid Based Anesthesia Protocol · Wilcoxon (Mann-Whitney) · p = 0.9762
  • Opioid Sparing Anesthesia Protocol vs Opioid Based Anesthesia Protocol · Wilcoxon (Mann-Whitney) · p = 0.9762
  • Opioid Sparing Anesthesia Protocol vs Opioid Based Anesthesia Protocol · Wilcoxon (Mann-Whitney) · p = 0.9762
  • Opioid Sparing Anesthesia Protocol vs Opioid Based Anesthesia Protocol · Wilcoxon (Mann-Whitney) · p = 0.3636
  • Opioid Sparing Anesthesia Protocol vs Opioid Based Anesthesia Protocol · Wilcoxon (Mann-Whitney) · p = 0.9762
  • Opioid Sparing Anesthesia Protocol vs Opioid Based Anesthesia Protocol · Wilcoxon (Mann-Whitney) · p = 0.6632
SecondaryPost Anesthesia Care Unit

Post anesthesia care unit (PACU) length of stay (hours) in each group will be recorded.

Time frame:
from PACU admission until PACU discharge
Reported as:
Median · hours
Post Anesthesia Care Unit
hoursOpioid Sparing Anesthesia ProtocolOpioid Based Anesthesia Protocol
Post Anesthesia Care Unit2.1 (1.8 to 3.6)2.3 (1.6 to 3.8)
Statistical analysis
  • Opioid Sparing Anesthesia Protocol vs Opioid Based Anesthesia Protocol · Wilcoxon (Mann-Whitney) · p = 0.8055
SecondaryHospital Length of Stay

Hospital length of stay (hours) in each group will be recorded.

Time frame:
from hospital admission for hernia surgery until hospital discharge
Reported as:
Median · hours
Hospital Length of Stay
hoursOpioid Sparing Anesthesia ProtocolOpioid Based Anesthesia Protocol
Hospital Length of Stay28 (8 to 31)24 (9 to 28)
Statistical analysis
  • Opioid Sparing Anesthesia Protocol vs Opioid Based Anesthesia Protocol · Wilcoxon (Mann-Whitney) · p = 0.4133
SecondaryIncidence of Post Operative Nausea and Vomiting (PONV )

Incidence of post operative nausea and vomiting in each group will be recorded.

Time frame:
during post anesthesia care unit stay (up to 3 hours), postoperative Day 1, during hospital stay (up to 7 days)
Reported as:
Count of participants · Participants
Incidence of Post Operative Nausea and Vomiting (PONV )
ParticipantsOpioid Sparing Anesthesia ProtocolOpioid Based Anesthesia Protocol
Incidence of PONV in PACU (Yes)55
Incidence of PONV during hospital stay excluding PACU (Yes)45
Incidence of PONV during overall hospital stay (Yes)69
Statistical analysis
  • Opioid Sparing Anesthesia Protocol vs Opioid Based Anesthesia Protocol · Fisher Exact · p = 0.8822
  • Opioid Sparing Anesthesia Protocol vs Opioid Based Anesthesia Protocol · Fisher Exact · p = 0.8171
  • Opioid Sparing Anesthesia Protocol vs Opioid Based Anesthesia Protocol · Fisher Exact · p = 0.4592
SecondaryRate of Rehospitalization

Rate of rehospitalization will be recorded for each group up to 30 days after hiatal hernia surgery.

Time frame:
within 30 days of surgery
Reported as:
Count of participants · Participants
Rate of Rehospitalization
ParticipantsOpioid Sparing Anesthesia ProtocolOpioid Based Anesthesia Protocol
Rate of Rehospitalization21
Statistical analysis
  • Opioid Sparing Anesthesia Protocol vs Opioid Based Anesthesia Protocol · Fisher Exact · p = 0.5020
SecondaryRate of Reoperation

Rate of reoperation will be recorded for each group up to 30 days after hiatal hernia surgery.

Time frame:
within 30 days of surgery
Reported as:
Count of participants · Participants
Rate of Reoperation
ParticipantsOpioid Sparing Anesthesia ProtocolOpioid Based Anesthesia Protocol
Rate of Reoperation11
Statistical analysis
  • Opioid Sparing Anesthesia Protocol vs Opioid Based Anesthesia Protocol · Fisher Exact · p = 0.9520
SecondaryRate of Emergency Room Visit

Rate of emergency room visits will be recorded up to 30 days after hiatal hernia surgery.

Time frame:
within 30 days of surgery
Reported as:
Count of participants · Participants
Rate of Emergency Room Visit
ParticipantsOpioid Sparing Anesthesia ProtocolOpioid Based Anesthesia Protocol
Rate of Emergency Room Visit31
Statistical analysis
  • Opioid Sparing Anesthesia Protocol vs Opioid Based Anesthesia Protocol · Fisher Exact · p = 0.2574
SecondarySurgeon 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)

Time frame:
within 30 minutes after surgery
Reported as:
Count of participants · Participants
Surgeon Satisfaction With Surgical Conditions
ParticipantsOpioid Sparing Anesthesia ProtocolOpioid Based Anesthesia Protocol
1 (Very dissatisfied)00
2 (Somewhat dissatisfied)00
3 (Neutral)00
4 (Somewhat satisfied)11
5 (Very satisfied)2224
Statistical analysis
  • Opioid Sparing Anesthesia Protocol vs Opioid Based Anesthesia Protocol · Fisher Exact · p = 0.9520
SecondaryVAS 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.

Time frame:
Postoperative days 1, 2, 3, 4, 5, 6, 7.
Reported as:
Count of participants · Participants
VAS Pain Severity Postoperative Days 1-7
ParticipantsOpioid Sparing Anesthesia ProtocolOpioid Based Anesthesia Protocol
Postoperative Day 1 — Mild Pain (VAS = 0-3)45
Postoperative Day 1 — Moderate Pain (VAS = 4-6)1310
Postoperative Day 1 — Severe Pain (VAS = 7-10)610
Postoperative Day 2 — Mild Pain (VAS = 0-3)56
Postoperative Day 2 — Moderate Pain (VAS = 4-6)1211
Postoperative Day 2 — Severe Pain (VAS = 7-10)68
Postoperative Day 3 — Mild Pain (VAS = 0-3)108
Postoperative Day 3 — Moderate Pain (VAS = 4-6)711
Postoperative Day 3 — Severe Pain (VAS = 7-10)66
Postoperative Day 4 — Mild Pain (VAS = 0-3)1213
Postoperative Day 4 — Moderate Pain (VAS = 4-6)512
Postoperative Day 4 — Severe Pain (VAS = 7-10)60
Postoperative Day 5 — Mild Pain (VAS = 0-3)1116
Postoperative Day 5 — Moderate Pain (VAS = 4-6)67
Postoperative Day 5 — Severe Pain (VAS = 7-10)62
Postoperative Day 6 — Mild Pain (VAS = 0-3)1519
Postoperative Day 6 — Moderate Pain (VAS = 4-6)46
Postoperative Day 6 — Severe Pain (VAS = 7-10)40
Postoperative Day 7 — Mild Pain (VAS = 0-3)1919
Postoperative Day 7 — Moderate Pain (VAS = 4-6)16
Postoperative Day 7 — Severe Pain (VAS = 7-10)30
Statistical analysis
  • Opioid Sparing Anesthesia Protocol vs Opioid Based Anesthesia Protocol · Fisher Exact · p = 0.5188
  • Opioid Sparing Anesthesia Protocol vs Opioid Based Anesthesia Protocol · Fisher Exact · p = 0.8448
  • Opioid Sparing Anesthesia Protocol vs Opioid Based Anesthesia Protocol · Fisher Exact · p = 0.5976
  • Opioid Sparing Anesthesia Protocol vs Opioid Based Anesthesia Protocol · Fisher Exact · p = .0092
  • Opioid Sparing Anesthesia Protocol vs Opioid Based Anesthesia Protocol · Fisher Exact · p = 0.2763
  • Opioid Sparing Anesthesia Protocol vs Opioid Based Anesthesia Protocol · Fisher Exact · p = 0.1137
  • Opioid Sparing Anesthesia Protocol vs Opioid Based Anesthesia Protocol · Fisher Exact · p = 0.0316
SecondaryTotal Ketorolac Dose

Total Ketorolac dose administered intraoperatively and postoperatively until hospital discharge

Time frame:
From hospital admission until hospital discharge
Reported as:
Mean · mg
Total Ketorolac Dose
mgOpioid Sparing Anesthesia ProtocolOpioid Based Anesthesia Protocol
Total Ketorolac Dose28.7 ± 31.330.6 ± 21.0
Statistical analysis
  • Opioid Sparing Anesthesia Protocol vs Opioid Based Anesthesia Protocol · Wilcoxon (Mann-Whitney) · p = 0.8042

Adverse events

Collected over From enrollment until end of follow-up 30 days after date of surgery.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Opioid Sparing Anesthesia Protocol0/23 (0%)2/23 (8.7%)2/23 (8.7%)
Opioid Based Anesthesia Protocol0/25 (0%)1/25 (4%)1/25 (4%)
Most frequent serious events
Most frequent serious events
EventOpioid Sparing Anesthesia ProtocolOpioid Based Anesthesia Protocol
Emergency room admission > 24 hours due to heart failureCardiac disorders1/230/25
Surgical complications requiring reoperationInjury, poisoning and procedural complications1/230/25
Hospital admission > 24 hours due to strep toxic shock syndromeInfections and infestations0/231/25
Most frequent other events
Most frequent other events
EventOpioid Sparing Anesthesia ProtocolOpioid Based Anesthesia Protocol
Emergency room visit < 24 hoursGastrointestinal disorders1/230/25
Planned unrelated surgical procedure during study follow-up periodSurgical and medical procedures1/230/25
Emergency room visit < 24 hours prior to study intervention taking placeGastrointestinal disorders0/231/25

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Opioid Sparing Anesthesia ProtocolOpioid Based Anesthesia ProtocolTotal
Mean65 ± 967 ± 966 ± 9
Sex: Female, Male
Sex: Female, Male(Participants)Opioid Sparing Anesthesia ProtocolOpioid Based Anesthesia ProtocolTotal
Female171835
Male6713
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Opioid Sparing Anesthesia ProtocolOpioid Based Anesthesia ProtocolTotal
Race — Caucasian222446
Race — Asian011
Race — Other/Unknown101
Height
Height(Meters)Opioid Sparing Anesthesia ProtocolOpioid Based Anesthesia ProtocolTotal
Mean1.8 ± 0.21.7 ± 0.11.7 ± 0.2
Weight
Weight(Kilograms)Opioid Sparing Anesthesia ProtocolOpioid Based Anesthesia ProtocolTotal
Mean91.0 ± 19.678.7 ± 17.184.6 ± 19.2
BMI
BMI(kg/m²)Opioid Sparing Anesthesia ProtocolOpioid Based Anesthesia ProtocolTotal
Mean31.0 ± 5.628.7 ± 4.729.8 ± 5.2
ASA Status
ASA Status(Participants)Opioid Sparing Anesthesia ProtocolOpioid Based Anesthesia ProtocolTotal
2101323
3131225
System Comorbidities (Yes)
System Comorbidities (Yes)(Participants)Opioid Sparing Anesthesia ProtocolOpioid Based Anesthesia ProtocolTotal
Liver (Yes)011
Kidney (Yes)101
Endocrine (Yes)8513
Respiratory (Yes)91019
Neurological (Yes)011
Cardiac (Yes)181735

4 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Endeavor Health
    Evanston, Illinois 60201, United States
09

References and documents

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 32584407 ↗
  • Bastawrous 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 33569727 ↗
  • Siu 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 32004171 ↗
  • Bakan 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 25925031 ↗
  • Hoffman 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 35703966 ↗
  • Anderson 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 11369161 ↗
  • Wengritzky 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 documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2024 to primary completion in Jan 2026, 22 months.

Results were first posted in Aug 2026, 6 months after primary completion.

Of 33 interventional studies with no phase under Hernia, Hiatal, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 68. This study's 22 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 5, 2023
First posted
Jul 20, 2023
StartActual
Mar 3, 2024
Primary completionActual
Jan 23, 2026
CompletionActual
Apr 30, 2026
Results first posted
Aug 13, 2026
Last update
Nov 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Results
Posted results revised
revised Nov 4, 2026
Primary outcomes
1 time frame changed, 1 description edited
What changed in the outcomes
  • Time frameThe Difference in Discharge Opioid Consumption in Morphine Milligram Equivalents (MMEs)Postoperative day 1,2, 3, 4, 5, 6 and 7. → From hospital discharge through postoperative day 7.
  • DescriptionThe Difference in Discharge Opioid Consumption in Morphine Milligram Equivalents (MMEs): how it is measured was reworded
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    Posted results revised
    Primary outcomes 1 time frame changed, 1 description edited
    What changed in the outcomes
    • Time frameThe Difference in Discharge Opioid Consumption in Morphine Milligram Equivalents (MMEs)Postoperative day 1,2, 3, 4, 5, 6 and 7. → From hospital discharge through postoperative day 7.
    • DescriptionThe Difference in Discharge Opioid Consumption in Morphine Milligram Equivalents (MMEs): how it is measured was reworded
    + 2 other changes: verification date and registry notes

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT05953428
Lead sponsor
Endeavor Health
Responsible party
Steven Greenberg (Jeffery S. Vender Endowed Chair of Anesthesiology Research and Education, Endeavor Health) — Principal investigator
First posted
Jul 20, 2023
Start date
Mar 3, 2024
Primary completion
Jan 23, 2026
Completion
Apr 30, 2026
Results posted
Aug 13, 2026
Last update
Nov 4, 2026

Study contacts

Steven Greenberg, MD
principal investigator · Endeavor Health

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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