Efficacy of Perioperative Opioid Sparing Techniques on Time to Initiation of Chemotherapy
Recruiting · NCT07153614 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Tennessee Graduate School of Medicine
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- Chronic Opioid Use (received an opioid within 90 days preoperatively)
- Recreational Drug Use
- Patients with cognitive impairments that can affect their ability to give consent
- Patients that are currently taking anti-coagulants \<7 days prior to surgery
- Pregnant or breastfeeding
- 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
- 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
Where it is running
1 location listed across 1 US state.
- University of Tennessee Graduate School of Medicine - Knoxville, Tennessee, United States