RECRUITING

IV vs Epidural Opioids + Epidural Local Anesthetic for Laparotomy Analgesia

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this research study is to determine if the two common ways of administering additional opioids (morphine like substance, narcotic) with an epidural, either mixed in the epidural solution or given separately through the intravenous, are equally effective in controlling post-operative pain

Official Title

Randomized Controlled Study Comparing the Administration of Opioids Epidurally vs IV in Patients Undergoing Laparotomy With an Epidural for Post-Operative Analgesia

Quick Facts

Study Start:2024-09-17
Study Completion:2024-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06559969

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.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age including and between 18 to 85 years old
  2. 2. Planned open abdominal procedure with an incision that is or includes above the umbilicus, where epidural would normally be offered and epidural would be maintained for an average of 4 to 5 days
  3. 3. Patient has consented for an epidural
  4. 4. Patient is able to converse in English
  5. 5. Patient is able to use a patient controlled pump
  1. 1. Has a known contraindication for an epidural
  2. 2. Known mental or cognitive disability
  3. 3. History of chronic opioid use or substance abuse disorder
  4. 4. Pre-operative use of opioids
  5. 5. History of chronic pain
  6. 6. Routine use of marijuana
  7. 7. Incarcerated
  8. 8. Unable to converse in English
  9. 9. Planned to remain intubated post-operatively
  10. 10. Need for post-operative use of anticoagulant regiment that would be contraindicated with an indwelling epidural catheter
  11. 11. End stage renal disease or dialysis
  12. 12. Hepatic disease that affects metabolism of drugs
  13. 13. Known contraindication to any of the study drugs
  14. 14. Known pregnancy or positive pre-operative pregnancy test
  15. 15. Known neurological condition that may affect motor or sensory systems

Contacts and Locations

Study Contact

Melinda Seering, MD
CONTACT
3193848411
Melinda-Seering@uiowa.edu
Yair Rubin, MD
CONTACT
3193587989
yair-rubin@uiowa.edu

Principal Investigator

Melinda Seering, MD
PRINCIPAL_INVESTIGATOR
Univeristy of Iowa

Study Locations (Sites)

University of Iowa Health Care
Iowa City, Iowa, 52242
United States

Collaborators and Investigators

Sponsor: University of Iowa

  • Melinda Seering, MD, PRINCIPAL_INVESTIGATOR, Univeristy of Iowa

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

Study Start Date2024-09-17
Study Completion Date2024-12-30

Study Record Updates

Study Start Date2024-09-17
Study Completion Date2024-12-30

Terms related to this study

Keywords Provided by Researchers

  • Epidural
  • PCEA
  • PCA
  • Hydromorphone
  • bupivacaine
  • analgesia
  • laparotomy

Additional Relevant MeSH Terms

  • Laparotomy