ClinicalTrials.gg
TerminatedNCT04137770Updated Nov 25, 2024

Application of the ICE-T Postoperative Multimodal Pain Regimen to Laparoscopic Hysterectomy

An interventional study of Ice pack and ketorolac in Pain, Postoperative, sponsored by Mercy Research. Terminated at 1 site in United States. Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-25.

Sponsored by Mercy Research · Not applicable, Interventional, and Treatment

Why this study was terminated
lack of enrollment, change of OR policies due to COVID
Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 1,180 studies in Pain, Postoperative with a site in United States — 204 open to participants now, 237 under way, 26 of them phase 3. Pain, Postoperative · United States.

Enrollment
946th of 1,098
18 · median 76
Started
2020
with 85 others
No phase
373 of 1,180
68 open now
Registered
669th of 1,180
by date

Among the 1,180 studies in Pain, Postoperative with a site in United States, this one is the 946th largest by enrollment of the 1,098 interventional ones, is one of 86 that started in 2020, is one of 373 with no phase, and was the 669th registered.

By phase

1,180 studies; the count open now beside each. This study's row is marked.

No phasethis study373 · 68 open
Phase 4359 · 72 open
Phase 3162 · 19 open
Phase 2121 · 9 open
Observational82 · 18 open
Phase 149 · 9 open
Phase 1/217 · 6 open
Phase 2/317 · 3 open

By the year they started

First in 1996; this study’s year is marked. 86 started in 2020.

Size and results

Median enrollment 76 across the 1,098 interventional studies, 130 across the 82 observational. Of the 783 that completed or were terminated, 474 (61%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 1,180 studies in Pain, Postoperative with a site in United States, or all of them as a file.
02

Study summary

This is a randomized controlled trial evaluating whether application of ice packs and scheduled ketorolac to the surgical site after laparoscopic hysterectomy reduces need for narcotic medications.

Read the detailed description

Patients who undergo laparoscopic hysterectomy and chose to participate in the study will be randomized to either receive the standard post-surgical analgesic protocol (control group) or the standard post-surgical analgesic protocol plus scheduled ketorolac and surgical site ice packs. Usage of narcotic analgesics for breakthrough pain will be monitored and compared between cohorts. All care received by test subjects will be standard of care, with the only difference being the use of ice packs and scheduled ketorolac.

03

Conditions studied

  • Pain, Postoperative

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04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
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

Females, 18-65 years old at time of new patient evaluation, Planned laparoscopic hysterectomy only or hysterectomy with or without unilateral or bilateral oophorectomy or salpingo-oophorectomy by Dr. Corey Wagner, Uterus with expected size greater than 250 grams as determined by bimanual exam or standard of care ultrasound obtained prior to or as part of new patient evaluation

Exclusion criteria

Exclusion Criteria:

Diagnosed or suspected endometriosis, Diagnosis of malignant carcinoma of the uterus, ovaries, or fallopian tubes, Diagnosis of severe renal disease (as determined by a of less than 45), Known nonsteroidal anti-inflammatory drug (NSAID) intolerance, History of myocardial infarction, stroke or other cardiovascular disease, Known or allergic reactions to Acetaminophen, Toradol, Ibuprofen, other NSAIDs, Aspirin or Roxicodone, Previous diagnosis of liver disease or hepatitis, Unable to take Tylenol (acetaminophen), Pre-existing narcotic drug regimens or opioid use disorders, Known diagnosis of or history of peptic ulcer disease, gastrointestinal bleeding or perforation, Known or suspected gastrointestinal obstruction including paralytic ileus, Diagnosis of severe bronchial asthma, Known diagnosis or history of cerebrovascular bleeding, Known bleeding disorder or coagulopathy based on patient history unless excluded by appropriate hematological examination, Daily prescription NSAID use, Adults unable to consent, Pregnancy as determined by urine or serum pregnancy test obtained in women of child-bearing age, Prisoners, Individuals who do not read and understand English

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • No intervention
    control

    Patients will receive routine post-operative analgesics

  • Experimental
    intervention

    Patients will receive routine post-operative analgesics plus scheduled ketorolac and surgical site ice packs

    Other: Ice pack and ketorolac

Interventions

  • OtherIce pack and ketorolac

    Scheduled IV ketorolac will be administered and ice packs will be applied to the surgical site

06

What researchers measure

Primary outcomes

  1. Opioid analgesic usage in the 24 hours immediate post-operative period

    Opioid analgesic usage in the 24 hours immediately post-operative as measured in Morphine Milligram Equivalents

    Time frame: 24 hours

Secondary outcomes

  1. Opioid analgesic usage for 6 weeks post-operative

    Opioid analgesic usage for 6 weeks post-operative as measured in Morphine Milligram Equivalents

    Time frame: 6 weeks

  2. Pain scores in the 24 hours immediate post-operative period

    Pain scores (on a scale of 1-10, 10 being worse pain) as documented by the floor nurse in the patient's chart in the 24 hours immediate post-operative period

    Time frame: 24 hours

07

Study locations

1 site
  • Mercy Hospital St. Louis
    St. Louis, Missouri 63141, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2020 to primary completion in Feb 2021, 11 months.

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

Registered
Oct 18, 2019
First posted
Oct 24, 2019
StartActual
Feb 4, 2020
Primary completionActual
Feb 1, 2021
CompletionActual
Mar 8, 2022
Last update
Nov 25, 2024
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.
No changes since tracking began. The registry record was last updated on Nov 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04137770
Lead sponsor
Mercy Research
Responsible party
Sponsor
First posted
Oct 24, 2019
Start date
Feb 4, 2020
Primary completion
Feb 1, 2021
Completion
Mar 8, 2022
Last update
Nov 25, 2024

Study contacts

Corey A Wagner, MD
principal investigator · Mercy St. Louis

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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