Application of the ICE-T Postoperative Multimodal Pain Regimen to Laparoscopic Hysterectomy
- Conditions
- Pain, Postoperative
- Interventions
- Other: Ice pack and ketorolac
- Registration Number
- NCT04137770
- Lead Sponsor
- Mercy Research
- 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 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 18
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description intervention Ice pack and ketorolac Patients will receive routine post-operative analgesics plus scheduled ketorolac and surgical site ice packs
- Primary Outcome Measures
Name Time Method Opioid analgesic usage in the 24 hours immediate post-operative period 24 hours Opioid analgesic usage in the 24 hours immediately post-operative as measured in Morphine Milligram Equivalents
- Secondary Outcome Measures
Name Time Method Opioid analgesic usage for 6 weeks post-operative 6 weeks Opioid analgesic usage for 6 weeks post-operative as measured in Morphine Milligram Equivalents
Pain scores in the 24 hours immediate post-operative period 24 hours 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
Trial Locations
- Locations (1)
Mercy Hospital St. Louis
🇺🇸St. Louis, Missouri, United States