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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04137770
• Other study ID #: 20-002
• Status: Terminated
• Phase: N/A
• Start date: February 4, 2020
• Est. completion date: March 8, 2022

Study information

• Verified date: March 2022
• Source: Mercy Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: March 8, 2022
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Other:
• Ice pack and ketorolac
Scheduled IV ketorolac will be administered and ice packs will be applied to the surgical site

Locations

Country	Name	City	State
United States	Mercy Hospital St. Louis	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Mercy Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 hours
Secondary	Opioid analgesic usage for 6 weeks post-operative	Opioid analgesic usage for 6 weeks post-operative as measured in Morphine Milligram Equivalents	6 weeks
Secondary	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	24 hours