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Terminated
lack of enrollment, change of OR policies due to COVID

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

ClinicalTrials.gov ID NCT04137770
Sponsor Mercy Research
Information provided by Mercy Research (Responsible Party)
Last Update Posted 2024-11-25
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Study Overview

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.
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Official Title
Application of the ICE-T Postoperative Multimodal Pain Regimen to Laparoscopic Hysterectomy
Conditions
Pain, Postoperative
Intervention / Treatment
  • Other: Ice pack and ketorolac
  • Other: Ice pack and ketorolac
Other Study ID Numbers
  • 20-002
Study Start (Actual)
2020-02-04
Primary Completion (Actual)
2021-02-01
Study Completion (Actual)
2022-03-08
Enrollment (Actual)
18
Study Type
Interventional
Phase
Not Applicable

Contacts and Locations

This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.

To learn more, please see the Contacts and Locations section in How to Read a Study Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).

This study has 1 location
United States
Missouri Locations
St. Louis, Missouri, United States, 63141

Mercy Hospital St. Louis
Click to view interactive map

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
Eligibility Criteria
Description

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:

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

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Ages Eligible for Study
18 Years to 65 Years (AdultOlder Adult )
Sexes Eligible for Study
Female
Accepts Healthy Volunteers
Yes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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Design Details
Primary Purpose : Treatment
Allocation : Randomized
Interventional Model : Parallel Assignment
Masking : None (Open Label)

Arms and Interventions

Participant Group/Arm Intervention/Treatment
Participant Group/Arm No Intervention: control
Patients will receive routine post-operative analgesics
Intervention/Treatment
Participant Group/Arm Experimental: intervention
Patients will receive routine post-operative analgesics plus scheduled ketorolac and surgical site ice packs
Intervention/Treatment Other: Ice pack and ketorolac
  • Scheduled IV ketorolac will be administered and ice packs will be applied to the surgical site

Primary Outcome Measures
Outcome Measure Measure Description Time Frame
Opioid analgesic usage in the 24 hours immediate post-operative periodOpioid analgesic usage in the 24 hours immediately post-operative as measured in Morphine Milligram Equivalents24 hours
Secondary Outcome Measures
Outcome Measure Measure Description Time Frame
Opioid analgesic usage for 6 weeks post-operativeOpioid analgesic usage for 6 weeks post-operative as measured in Morphine Milligram Equivalents6 weeks
Pain scores in the 24 hours immediate post-operative periodPain 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 period24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.
Sponsor
Mercy Research
Investigators
  • Principal Investigator:Corey A Wagner, MD,Mercy St. Louis

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
2019-10-18
First Submitted that Met QC Criteria
2019-10-22
First Posted
2019-10-24
Study Record Updates
Last Update Submitted that met QC Criteria
2024-11-21
Last Update Posted
2024-11-25
Last Verified
2024-11

More Information

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Additional Relevant MeSH Terms

Plan to Share Individual Participant Data (IPD)?
No