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

Primary Purpose

Pain, Postoperative

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ice pack and ketorolac
Sponsored by
Mercy Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Mercy Hospital St. Louis

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control

intervention

Arm Description

Patients will receive routine post-operative analgesics

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 18, 2019
Last Updated
March 31, 2022
Sponsor
Mercy Research
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1. Study Identification

Unique Protocol Identification Number
NCT04137770
Brief Title
Application of the ICE-T Postoperative Multimodal Pain Regimen to Laparoscopic Hysterectomy
Official Title
Application of the ICE-T Postoperative Multimodal Pain Regimen to Laparoscopic Hysterectomy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
lack of enrollment, change of OR policies due to COVID
Study Start Date
February 4, 2020 (Actual)
Primary Completion Date
February 1, 2021 (Actual)
Study Completion Date
March 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mercy Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
No Intervention
Arm Description
Patients will receive routine post-operative analgesics
Arm Title
intervention
Arm Type
Experimental
Arm Description
Patients will receive routine post-operative analgesics plus scheduled ketorolac and surgical site ice packs
Intervention Type
Other
Intervention Name(s)
Ice pack and ketorolac
Intervention Description
Scheduled IV ketorolac will be administered and ice packs will be applied to the surgical site
Primary Outcome Measure Information:
Title
Opioid analgesic usage in the 24 hours immediate post-operative period
Description
Opioid analgesic usage in the 24 hours immediately post-operative as measured in Morphine Milligram Equivalents
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Opioid analgesic usage for 6 weeks post-operative
Description
Opioid analgesic usage for 6 weeks post-operative as measured in Morphine Milligram Equivalents
Time Frame
6 weeks
Title
Pain scores in the 24 hours immediate post-operative period
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corey A Wagner, MD
Organizational Affiliation
Mercy St. Louis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mercy Hospital St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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