NCT07153614 Efficacy of Perioperative Opioid Sparing Techniques on Time to Initiation of Chemotherapy
| NCT ID | NCT07153614 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Tennessee Graduate School of Medicine |
| Condition | Perioperative Opioid Sparing Techniques |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-02-03 |
| Primary Completion | 2027-02-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2025-02-03 with a primary completion date of 2027-02-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. 18-80 years of age 2. Patients undergoing open surgery for foregut, HPB, and colorectal cancer 3. Able to read and understand study procedures 4. Willing to participate and sign an ICF 5. If female of childbearing potential, subject must have a negative pregnancy test 6. Recommended for adjuvant chemotherapy 7. Patients scheduled for an AM admit procedure 8. English speaking 9. Patients with a midline incision Exclusion Criteria: 1. Chronic Opioid Use (received an opioid within 90 days preoperatively) 2. Recreational Drug Use 3. Patients with cognitive impairments that can affect their ability to give consent 4. Patients that are currently taking anti-coagulants \<7 days prior to surgery 5. Pregnant or breastfeeding 6. Does not require adjuvant chemotherapy 7. Relative Contradictions for receiving a nerve block\* 8. Patients that have been admitted prior to surgery for chief complaint related to complications from malignancy 9. Inability to provide consent * Absolute Contraindications * Lack of patient consent. * Skin infection at the site of needle insertion. Relative Contraindications * Coagulopathy * Systemic infection * Anatomical distortion * Neuropathy Drugs/Device usage within 7 Days of Randomization if any: • Anticoagulants
Frequently Asked Questions
Who can join the NCT07153614 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Perioperative Opioid Sparing Techniques. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07153614 currently recruiting?
Yes, NCT07153614 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Tennessee Graduate School of Medicine to inquire about joining.
Where is the NCT07153614 trial being conducted?
This trial is being conducted at Knoxville, United States.
Who is sponsoring the NCT07153614 clinical trial?
NCT07153614 is sponsored by University of Tennessee Graduate School of Medicine. The trial plans to enroll 200 participants.