Actively Recruiting
Efficacy of Perioperative Opioid Sparing Techniques on Time to Initiation of Chemotherapy
Led by University of Tennessee Graduate School of Medicine · Updated on 2025-09-04
200
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy of Perioperative Opioid Sparing Techniques on Time to Initiation of Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Undergoing open surgery for foregut, HPB, or colorectal cancer
- Able to read and understand the study procedures
- Willing to participate and sign informed consent
- Negative pregnancy test if female of childbearing potential
- Recommended for adjuvant chemotherapy
- Scheduled for an AM admit procedure
- English speaking
- Surgery involves a midline incision
You will not qualify if you...
- Chronic opioid use within 90 days before surgery
- Recreational drug use
- Cognitive impairments affecting ability to consent
- Taking anticoagulants within 7 days before surgery
- Pregnant or breastfeeding
- Not requiring adjuvant chemotherapy
- Relative contraindications for nerve block including coagulopathy, systemic infection, anatomical distortion, neuropathy
- Admission prior to surgery due to malignancy complications
- Inability to provide consent
- Skin infection at needle insertion site
- Lack of patient consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Tennessee Graduate School of Medicine
Knoxville, Tennessee, United States, 37920
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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