Status:
TERMINATED
Application of the ICE-T Postoperative Multimodal Pain Regimen to Laparoscopic Hysterectomy
Lead Sponsor:
Mercy Research
Conditions:
Pain, Postoperative
Eligibility:
FEMALE
18-65 years
Phase:
NA
Brief 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.
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 ...
Eligibility Criteria
Inclusion
- 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
- Diagnosed or suspected endometriosis, Diagnosis of malignant carcinoma of the uterus, ovaries, or fallopian tubes, Diagnosis of severe renal disease (as determined by a GFR of less than 45), Known nonsteroidal anti-inflammatory drug (NSAID) intolerance, History of myocardial infarction, stroke or other cardiovascular disease, Known hypersensitivity 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
Key Trial Info
Start Date :
February 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 8 2022
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04137770
Start Date
February 4 2020
End Date
March 8 2022
Last Update
November 25 2024
Active Locations (1)
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1
Mercy Hospital St. Louis
St Louis, Missouri, United States, 63141