RECRUITING

Efficacy of Perioperative Opioid Sparing Techniques on Time to Initiation of Chemotherapy

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 primary purpose of this study is to determine if intrathecal morphine (ITM) administration is superior to quadratus lumborum block or surgeon administered transversus abdominis plane (TAP) blocks result in decreased time to initiation of chemotherapy following oncologic surgery. The secondary objectives of this study are to determine: * The difference between interventions in time to return of bowel function in days * The difference between interventions in incidence of opioid related adverse drug events (ORADEs) * The difference between interventions in cumulative and post-operative total morphine milligram equivalents * The difference between interventions in quality-of-life assessment tool and patient satisfaction (brief pain index short form BPI-sf9) * The difference between interventions in hospital length of stay in days * The difference between cumulative pain scores between interventions * The difference between short acting and long-acting bupivacaine in pain management and time to chemotherapy The hypothesis is that preoperative intrathecal morphine administration will significantly reduce the time to initiation of postoperative chemotherapy.

Official Title

Efficacy of Perioperative Opioid Sparing Techniques on Time to Initiation of Chemotherapy: A Randomized Single Blinded Control Study

Quick Facts

Study Start:2025-02-03
Study Completion:2027-02-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07153614

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 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 18-80 years of age
  2. 2. Patients undergoing open surgery for foregut, HPB, and colorectal cancer
  3. 3. Able to read and understand study procedures
  4. 4. Willing to participate and sign an ICF
  5. 5. If female of childbearing potential, subject must have a negative pregnancy test
  6. 6. Recommended for adjuvant chemotherapy
  7. 7. Patients scheduled for an AM admit procedure
  8. 8. English speaking
  9. 9. Patients with a midline incision
  1. 1. Chronic Opioid Use (received an opioid within 90 days preoperatively)
  2. 2. Recreational Drug Use
  3. 3. Patients with cognitive impairments that can affect their ability to give consent
  4. 4. Patients that are currently taking anti-coagulants \<7 days prior to surgery
  5. 5. Pregnant or breastfeeding
  6. 6. Does not require adjuvant chemotherapy
  7. 7. Relative Contradictions for receiving a nerve block\*
  8. 8. Patients that have been admitted prior to surgery for chief complaint related to complications from malignancy
  9. 9. Inability to provide consent
  10. * Absolute Contraindications
  11. * Lack of patient consent.
  12. * Skin infection at the site of needle insertion. Relative Contraindications
  13. * Coagulopathy
  14. * Systemic infection
  15. * Anatomical distortion
  16. * Neuropathy

Contacts and Locations

Study Locations (Sites)

University of Tennessee Graduate School of Medicine
Knoxville, Tennessee, 37920
United States

Collaborators and Investigators

Sponsor: University of Tennessee Graduate School of Medicine

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 Date2025-02-03
Study Completion Date2027-02-03

Study Record Updates

Study Start Date2025-02-03
Study Completion Date2027-02-03

Terms related to this study

Keywords Provided by Researchers

  • Opioid
  • Perioperative Opioid Sparing Techniques
  • Colorectal Cancer
  • Foregut Cancer
  • Hepatopancreatobiliary (HPB)

Additional Relevant MeSH Terms

  • Perioperative Opioid Sparing Techniques