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

NCT04137770 | Terminated DMC

• 1 other identifier: 20-002
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Opioid analgesic usage for 6 weeks post-operative

  6 weeks

• Pain scores in the 24 hours immediate post-operative period

  24 hours

Study Arms (2)

control

NO INTERVENTION

Patients will receive routine post-operative analgesics

intervention

EXPERIMENTAL

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

Other: Ice pack and ketorolac

Interventions

Ice pack and ketorolac OTHER

Scheduled IV ketorolac will be administered and ice packs will be applied to the surgical site

intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mercy Research: lead

Study Sites (1)

Mercy Hospital St. Louis

St Louis, Missouri, 63141, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ketorolac

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Corey A Wagner, MD

  Mercy St. Louis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2019
• First Posted: October 24, 2019
• Study Start: February 4, 2020
• Primary Completion: February 1, 2021
• Study Completion: March 8, 2022
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)