NCT07153614Recruiting
Efficacy of Perioperative Opioid Sparing Techniques on Time to Initiation of Chemotherapy
Efficacy of Perioperative Opioid Sparing Techniques on Time to Initiation of Chemotherapy: A Randomized Single Blinded Control Study
Source: ClinicalTrials.gov · Last updated 4 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 15 Aug 2025
- Start date
- 3 Feb 2025
- Primary completion date
- 3 Feb 2027
- Lead sponsor
- University of Tennessee Graduate School of Medicine
- Diseases
- Colorectal cancer
- NCT number
- NCT07153614
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 3 Feb 2025 to the primary completion date, 3 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Chronic Opioid Use (received an opioid within 90 days preoperatively)
- Recreational Drug Use
- Patients that are currently taking anti-coagulants \<7 days prior to surgery
- Does not require adjuvant chemotherapy
- Relative Contradictions for receiving a nerve block\*
- Patients that have been admitted prior to surgery for chief complaint related to complications from malignancy
Other illness
- 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:
Other
- Patients with cognitive impairments that can affect their ability to give consent
- Pregnant or breastfeeding
- Anticoagulants
Who the study is looking for
- 18-80 years of age
- Patients undergoing open surgery for foregut, HPB, and colorectal cancer
- Able to read and understand study procedures
- Willing to participate and sign an ICF
- If female of childbearing potential, subject must have a negative pregnancy test
- Recommended for adjuvant chemotherapy
- Patients scheduled for an AM admit procedure
- English speaking
- Patients with a midline incision
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Tennessee Graduate School of Medicine Coordinator of this site? Confirm its status | Knoxville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.