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

ConditionPerioperative Opioid Sparing Techniques
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Tennessee Graduate School of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intrathecal Morphine Block

    Procedure/Surgery

    Morphine 150 mcg

  • Bilateral Quadratus Lumborum Block

    Procedure/Surgery

    30 mL of 0.25% bupivacaine and 4mg of dexamethasone

  • Bilateral Transverse Abdominis Plane Block

    Procedure/Surgery

    Exparel-based solution mixed with 50mL of saline

Treatment groups

200 Participants
are divided into 3 treatment groups
Group A: ITM groupExperimental treatment 1 intervention
Group B: QL groupActive comparator 1 intervention
Group C: TAP block groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

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

Time frame
From end of surgery up to 14 days postoperatively
2

Incidence of ORADEs

Time frame
From baseline up to 90 days post-surgery
3

Cumulative and postoperative morphine milligram equivalents

Time frame
From baseline up to 90 days post-surgery
4

Hospital length of stay in days

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Tennessee Graduate School of Medicine

Lead sponsor

Source ClinicalTrials.gov
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