Efficacy of Perioperative Opioid Sparing Techniques on Time to Initiation of Chemotherapy
NCT07153614 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2025-09-04
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.
Conditions
- Perioperative Opioid Sparing Techniques
Interventions
- PROCEDURE
-
Intrathecal Morphine Block
Morphine 150 mcg
- PROCEDURE
-
Bilateral Quadratus Lumborum Block
30 mL of 0.25% bupivacaine and 4mg of dexamethasone
- PROCEDURE
-
Bilateral Transverse Abdominis Plane Block
Exparel-based solution mixed with 50mL of saline
Sponsors & Collaborators
-
University of Tennessee Graduate School of Medicine
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-03
- Primary Completion
- 2027-02-03
- Completion
- 2027-02-03
Countries
- United States
Study Locations
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