RecruitingNot ApplicableNCT07153614

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


Sponsor

University of Tennessee Graduate School of Medicine

Enrollment

200 participants

Start Date

Feb 3, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether using less opioid pain medication after major abdominal cancer surgery helps patients start chemotherapy sooner. Researchers will compare standard pain management to opioid-sparing techniques like nerve blocks. **You may be eligible if...** - You are between 18 and 80 years old - You are scheduled for open abdominal surgery for foregut, liver/pancreas/bile duct, or colorectal cancer - You are recommended to receive chemotherapy after surgery - You speak English and can understand the study - You do not currently use opioid painkillers (none in the past 90 days) **You may NOT be eligible if...** - You regularly use opioids or recreational drugs - You have cognitive problems that affect your ability to consent - You are currently taking blood thinners within 7 days of surgery - You are pregnant or breastfeeding - You have a contraindication to nerve blocks (e.g., blood clotting disorder, local infection, or neuropathy) - You do not require adjuvant chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREIntrathecal Morphine Block

Morphine 150 mcg

PROCEDUREBilateral Quadratus Lumborum Block

30 mL of 0.25% bupivacaine and 4mg of dexamethasone

PROCEDUREBilateral Transverse Abdominis Plane Block

Exparel-based solution mixed with 50mL of saline


Locations(1)

University of Tennessee Graduate School of Medicine

Knoxville, Tennessee, United States

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NCT07153614