Recruiting

ITM vs. TAP

Sponsor:

University of Tennessee Graduate School of Medicine

Code:

NCT07153614

Conditions

Perioperative Opioid Sparing Techniques

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Intrathecal Morphine Block

Bilateral Quadratus Lumborum Block

Bilateral Transverse Abdominis Plane Block

Study Details

Brief 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

Study ID

NCT07153614

Start date

Feb 3, 2025

Status verified date

Aug, 2025

Completion date

Feb 3, 2027

Anticipated

Primary completion date

Feb 3, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ITM group

Patients will receive an intrathecal morphine block performed by the Anesthesiologist. This will be accomplished by placing the patient in a preoperative holding room with standard ASA monitors 150 mcg of morphine will be administered intrathecally

active comparator: QL group

Patients will receive a bilateral quadratus lumborum block containing 30 mL of 0.25% bupivacaine and 4mg of dexamethasone. This will be accomplished by placing the patient in a preoperative holding room with standard ASA monitors where the bilateral quadratus lumborum block will be performed by the Anesthesiologist

active comparator: TAP block group

Patients will undergo a bilateral transverse abdominis plane block performed by the surgical team using an exparel-based solution mixed with 50mL of saline. This block will be performed intraoperatively before the incisions are closed

Interventions

Intrathecal Morphine Block

Morphine 150 mcg

Bilateral Quadratus Lumborum Block

30 mL of 0.25% bupivacaine and 4mg of dexamethasone

Bilateral Transverse Abdominis Plane Block

Exparel-based solution mixed with 50mL of saline

Primary outcome measure

  • Time to initiation of chemotherapy (in days) as deemed by a blinded medical oncologist [ Time Frame: Day of surgery to first chemotherapy session, assessed on (Day 30, Day 60, Day 90 visits) ]

Central Contacts and Locations

Locations

University of Tennessee Graduate School of Medicine

Recruiting

Knoxville, Tennessee, United States, 37920

Contacts

Study Coordinator: Lauren Crawford, MS

865-305-9308lcrawford@utmck.edu

Principal Investigator:

Che A. Solla MD, MBA

More Information

Sponsor

University of Tennessee Graduate School of Medicine

Last update posted

Sep 4, 2025

Last verified

Aug, 2025

Keywords

  • Opioid
  • Perioperative Opioid Sparing Techniques
  • Colorectal Cancer
  • Foregut Cancer
  • Hepatopancreatobiliary (HPB)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Tennessee Graduate School of Medicine on 2025-09-04.