Clinical trial · Interventional

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

Efficacy of Perioperative Opioid Sparing Techniques on Time to Initiation of Chemotherapy: A Randomized Single Blinded Control Study

NCT07153614CI-TRIAL-00094517recruitingN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Perioperative Opioid Sparing Techniques	—	UNRESOLVED	—

Interventions

Interventions (3)

Intervention	Type	Mapped drug	Match
Bilateral Quadratus Lumborum Block	Procedure	—	UNRESOLVED
Bilateral Transverse Abdominis Plane Block	Procedure	—	UNRESOLVED
Intrathecal Morphine Block	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (3)

type
EXPERIMENTAL
label
ITM group
description
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
interventionNames
1. Procedure: Intrathecal Morphine Block
type
ACTIVE_COMPARATOR
label
QL group
description
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
interventionNames
1. Procedure: Bilateral Quadratus Lumborum Block
type

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 80 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Feb 3, 2025
Primary completion: Feb 3, 2027
Completion: Feb 3, 2027
First posted: Sep 4, 2025
Last update posted: Sep 4, 2025
Enrollment: 200 (estimated)
Lead sponsor: University of Tennessee Graduate School of Medicine OTHER
Keywords: Opioid, Perioperative Opioid Sparing Techniques, Colorectal Cancer, Foregut Cancer, Hepatopancreatobiliary (HPB)

Data updated 22 days agoSource updated Sep 4, 2025source: clinicaltrials

Locations

Locations by country (1)

Country	Sites	Recruiting
United States	1	1

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.