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| ID | Type | Description | Link |
|---|---|---|---|
| Institutional Review Board | Other Identifier | The University of Tennessee Health Science Center |
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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 hypothesis is that preoperative intrathecal morphine administration will significantly reduce the time to initiation of postoperative chemotherapy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intrathecal Morphine Block | Procedure | Morphine 150 mcg |
| |
| Bilateral Quadratus Lumborum Block |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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
Drugs/Device usage within 7 Days of Randomization if any:
• Anticoagulants
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Tennessee Graduate School of Medicine | Recruiting | Knoxville | Tennessee | 37920 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 14, 2025 |
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| 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 |
|
| 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 |
| Patient satisfaction scores (Brief Pain Inventory - Short Form, Question 9 [BPI-sf9]) | Post-op 14, 30, 60, and 90 days. |
| Aug 15, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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