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

NCT ID: NCT07153614

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-03
• Study Completion Date: 2027-02-03

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.

Detailed Description

Enhanced recovery after surgery (ERAS) has become the standard of perioperative care for patients undergoing oncologic surgery. Multimodal and regional anesthetic techniques to reduce postoperative pain and opioid requirements are a key component of ERAS. Epidural analgesia was considered standard in early ERAS protocols. however, it is labor-intensive, requires close postoperative follow-up, and may exacerbate hemodynamic instability.

Long-acting intrathecal (IT) opioid use in oncologic surgery has been described as an equianalgesic technique to epidural analgesia with an improved safety profile, although both have the potential for neurological complications and respiratory depression9. Quadratus lumborum (QL) block is an alternative opioid sparing technique to neuraxial analgesia for abdominal surgery. QL blocks can provide similar pain coverage as an epidural with decreased hemodynamic instability. However, it is limited by its relatively short duration of effect, which ranges from 6 to 12 h. Another method employed is the transversus abdominis plane block. One of the advantages of this technique is that it does not depend on a separate service to perform like ITM and QL as it is commonly performed by the surgeon during surgery. However, unlike the QL block which has been shown to spread to the lumbar plexus and even thoracic paravertebral space providing both somatic and visceral analgesia, TAP blocks only provide somatic analgesia coverage. TAP blocks are still frequently performed by oncologic surgeons though the long term success compared to QL and ITM blocks is unclear. Most research looking into the efficacy of these techniques has been aimed at studying their effects on pain scores, opioid requirements, and opioid related adverse drug events.

Time to initiation of adjuvant chemotherapy (AC) following oncologic surgery is an important predictor of survivability that has not yet been considered in QL vs. IT comparison studies. Two meta-analyses demonstrated that postponing the postoperative AC was associated with poor survival in colorectal cancer patients. Results from Biagi et al. showed that every 4 weeks delay result in a 14% decrease of overall survival (OS). Similarly, Guetz's study indicated that delaying the initiation of AC for > 8 weeks after operation significantly decreased OS. In pancreatic and colorectal cancer, several factors are involved in this metric. One of the more common factors in this patient population is gastrointestinal complications including ileus. Some of these complications can be affected by perioperative opioid consumption.

Conditions

Perioperative Opioid Sparing Techniques

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Intrathecal Morphine Block

Intervention Type: PROCEDURE

Morphine 150 mcg

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

Group Type: ACTIVE_COMPARATOR

Bilateral Quadratus Lumborum Block

Intervention Type: PROCEDURE

30 mL of 0.25% bupivacaine and 4mg of dexamethasone

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

Group Type: ACTIVE_COMPARATOR

Bilateral Transverse Abdominis Plane Block

Intervention Type: PROCEDURE

Exparel-based solution mixed with 50mL of saline

Interventions

Intrathecal Morphine Block

Morphine 150 mcg

Intervention Type: PROCEDURE

Bilateral Quadratus Lumborum Block

30 mL of 0.25% bupivacaine and 4mg of dexamethasone

Intervention Type: PROCEDURE

Bilateral Transverse Abdominis Plane Block

Exparel-based solution mixed with 50mL of saline

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Tennessee Graduate School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Tennessee Graduate School of Medicine

Knoxville, Tennessee, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Study Coordinator: Lauren Crawford, MS

Role: primary

lcrawford@utmck.edu

865-305-9308

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Institutional Review Board

Identifier Type: OTHER

Identifier Source: secondary_id

5229

Identifier Type: -

Identifier Source: org_study_id