Efficacy of Perioperative Opioid Sparing Techniques on Time to Initiation of Chemotherapy

NCT07153614 | Recruiting

• 2 other identifiers: 5229Institutional Review Board
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Time to initiation of chemotherapy (in days) as deemed by a blinded medical oncologist

  Day of surgery to first chemotherapy session, assessed on (Day 30, Day 60, Day 90 visits)

Secondary Outcomes (6)

• Time (in hours) to Return of Bowel Function, Defined as First Passage of Flatus or Stool

  From end of surgery up to 14 days postoperatively

• Incidence of ORADEs

  From baseline up to 90 days post-surgery

• Cumulative and postoperative morphine milligram equivalents

  From baseline up to 90 days post-surgery

• Hospital length of stay in days

  Post-op to discharge, assessed up to 30 days postoperatively

• Pain scores measured by Visual Analog Scale (VAS), 0-10

  Postoperatively at 1, 2, and 6 hours after surgery (Day 0); at 24 and 48 hours (Days 1 and 2); and on Days 7, 30, 60, and 90

Study Arms (3)

ITM group

EXPERIMENTAL

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

Procedure: Intrathecal Morphine Block

QL group

ACTIVE COMPARATOR

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

Procedure: Bilateral Quadratus Lumborum Block

TAP block group

ACTIVE COMPARATOR

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

Procedure: Bilateral Transverse Abdominis Plane Block

Interventions

Intrathecal Morphine Block PROCEDURE

Morphine 150 mcg

ITM group

Bilateral Quadratus Lumborum Block PROCEDURE

30 mL of 0.25% bupivacaine and 4mg of dexamethasone

QL group

Bilateral Transverse Abdominis Plane Block PROCEDURE

Exparel-based solution mixed with 50mL of saline

TAP block group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Tennessee Graduate School of Medicine: lead

Study Sites (1)

University of Tennessee Graduate School of Medicine

Knoxville, Tennessee, 37920, United States

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: September 4, 2025
• Study Start: February 3, 2025
• Primary Completion (Estimated): February 3, 2027
• Study Completion (Estimated): February 3, 2027
• Last Updated: September 4, 2025

Record last verified: 2025-08

Locations

US (1)