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

Conditions

• Perioperative Opioid Sparing Techniques

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Intrathecal Morphine Block — PROCEDURE
  Morphine 150 mcg
• Bilateral Quadratus Lumborum Block — PROCEDURE
  30 mL of 0.25% bupivacaine and 4mg of dexamethasone
• Bilateral Transverse Abdominis Plane Block — PROCEDURE
  Exparel-based solution mixed with 50mL of saline

Study Details

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.

Key Dates

Start date

Feb 3, 2025

Status verified

Aug 2025

Primary completion

Feb 3, 2027

Completion

Feb 3, 2027

Study Design

Enrollment

200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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

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) ]

Locations (1)

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