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

NCT ID: NCT04137770

Last Updated: 2024-11-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-04
• Study Completion Date: 2022-03-08

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.

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

control

Patients will receive routine post-operative analgesics

Group Type: NO_INTERVENTION

No interventions assigned to this group

intervention

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

Group Type: EXPERIMENTAL

Ice pack and ketorolac

Intervention Type: OTHER

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

Interventions

Ice pack and ketorolac

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Mercy Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Corey A Wagner, MD

Role: PRINCIPAL_INVESTIGATOR

Mercy St. Louis

Locations

Mercy Hospital St. Louis

St Louis, Missouri, United States

Countries

United States

Other Identifiers

20-002

Identifier Type: -

Identifier Source: org_study_id