Perioperative opioid-sparing techniques to speed the start of chemotherapy after open foregut, HPB, or colorectal cancer surgery
Efficacy of Perioperative Opioid Sparing Techniques on Time to Initiation of Chemotherapy: A Randomized Single Blinded Control Study
This trial will test if intrathecal morphine, quadratus lumborum blocks, or surgeon‑performed TAP blocks help people having open foregut, HPB, or colorectal cancer surgery begin adjuvant chemotherapy sooner.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Tennessee Graduate School of Medicine Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Knoxville, Tennessee) |
| Trial ID | NCT07153614 on ClinicalTrials.gov |
What this trial studies
Adults undergoing open foregut, hepatopancreatobiliary (HPB), or colorectal cancer operations with a midline incision and planned adjuvant chemotherapy will be assigned to receive one of three perioperative opioid‑sparing analgesic approaches: intrathecal morphine, bilateral quadratus lumborum (QL) blocks, or bilateral transversus abdominis plane (TAP) blocks performed by the surgeon. The trial compares time to initiation of chemotherapy as the primary endpoint and collects secondary outcomes including return of bowel function, opioid‑related adverse events, cumulative opioid consumption, pain scores, quality of life (BPI‑sf9), hospital length of stay, and differences between short‑ and long‑acting bupivacaine. Eligible participants are adults aged 18–80 who can consent, speak English, and are scheduled for an AM admission for open cancer surgery. Patients with chronic opioid use, recent recreational drug use, anticoagulation issues, pregnancy, or contraindications to nerve blocks are excluded.
Who should consider this trial
Good fit: Adults aged 18–80 undergoing open foregut, HPB, or colorectal cancer surgery with a midline incision who are planned for adjuvant chemotherapy and can provide informed consent are the ideal candidates.
Not a fit: Patients on chronic opioids, those who do not require adjuvant chemotherapy, or those with contraindications to regional or neuraxial blocks are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, this approach could shorten the time to start adjuvant chemotherapy while reducing opioid use and opioid‑related side effects after cancer surgery.
How similar studies have performed: Prior studies have shown intrathecal opioids, QL blocks, and TAP blocks can reduce postoperative opioid needs and provide effective analgesia, but using these techniques specifically to speed initiation of adjuvant chemotherapy is a relatively novel application with limited direct evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. 18-80 years of age
2. Patients undergoing open surgery for foregut, HPB, and colorectal cancer
3. Able to read and understand study procedures
4. Willing to participate and sign an ICF
5. If female of childbearing potential, subject must have a negative pregnancy test
6. Recommended for adjuvant chemotherapy
7. Patients scheduled for an AM admit procedure
8. English speaking
9. Patients with a midline incision
Exclusion Criteria:
1. Chronic Opioid Use (received an opioid within 90 days preoperatively)
2. Recreational Drug Use
3. Patients with cognitive impairments that can affect their ability to give consent
4. Patients that are currently taking anti-coagulants \<7 days prior to surgery
5. Pregnant or breastfeeding
6. Does not require adjuvant chemotherapy
7. Relative Contradictions for receiving a nerve block\*
8. Patients that have been admitted prior to surgery for chief complaint related to complications from malignancy
9. 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 this trial is running
Knoxville, Tennessee
- University of Tennessee Graduate School of Medicine — Knoxville, Tennessee, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.