Repeat Quadratus Lumborum Block to Reduce Opioid Need in Patients After Pancreatic Surgery

Study Overview
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Brief Summary
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This phase II trial studies how an additional anesthetic nerve block, called a quadratus lumborum block, works to reduce the need for opioids in patients after pancreatic surgery. Giving an additional regional anesthetic after surgery may hasten the weaning process, reduce the need for opioid medications upon discharge, and reduce the risk of opioid dependence.

Detailed Description
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PRIMARY OBJECTIVE: I. To use a phase II randomized controlled trial to compare the intervention of a second regional anesthetic block (quadratus lumborum [QL] block) versus usual care (single intraoperative QL block) to increase the proportion of opioid-free pancreatic cancer survivors at discharge after potentially curative surgery. OUTLINE: Patients are randomized to 1 of 2 arms. ARM 1: Patients undergo QL block before surgery and receive standard of care multimodal pain control after surgery. ARM 2: Patients undergo QL block before surgery and receive multimodal pain control. Patients then undergo a second QL block on day 4 after surgery and continue to receive standard of care. After completion of study treatment, patients are followed up at 1 month, 3 months, 6 months, and 1 year after surgery.

Official Title
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Randomized Controlled Trial of Repeat vs. Single Quadratus Lumborum Block to Reduce Opioid Prescriptions After Open Pancreatectomy (RESQU-BLOCK Trial)

Conditions
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Pancreatic Carcinoma

Intervention / Treatment
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* Other: Best Practice
* Drug: Quadratus Lumborum Block
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing elective open pancreatic resection for potentially curative intent (pancreaticoduodenectomy or distal pancreatectomy) who would otherwise be treated with QL block + IV-PCA converted to oral pain meds (non-narcotic bundle + opioid pain pill). Exclusion Criteria: Patients with current or past substance (drug or alcohol) abuse disorder. Laparoscopic or minimally invasive surgery.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm I (QL block, standard of care)<br>Patients undergo QL block before surgery and receive standard of care multimodal pain control after surgery. | Other: Best Practice<br>* Given standard of care<br>* Other names: standard therapy;Drug: Quadratus Lumborum Block<br>* Undergo QL block<br>* Other names: QL Block;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: Arm II (second QL block)<br>Patients undergo QL block before surgery and receive multimodal pain control. Patients then undergo a second QL block on day 4 after surgery and continue to receive standard of care. | Other: Best Practice<br>* Given standard of care<br>* Other names: standard therapy;Drug: Quadratus Lumborum Block<br>* Undergo QL block<br>* Other names: QL Block;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Discharged Opioid-Free | Performed Chi-squared test to compare the proportion of patients who were opioid-free on the discharge date between the two arms | 90 days from surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Inpatient Oral Morphine Equivalents (OME) | Two sample t-test or Wilcoxon rank-sum test will be used. | Up to 1 year | 
| Hospital Cost | Two sample t-test. | Up to 1 year | 
| Quality of Life Score Assessed by MD Anderson Symptom Inventory-Gastrointestinal (MDASI-GI) | Two sample t-test or Wilcoxon rank-sum test will be used. | Up to 1 year | 
| Pain Prescription Dosage/Size | Two sample t-test or Wilcoxon rank-sum test will be used. | through study completion, an average of 1 year | 
| Percentage of Patients With Initial Discharge Prescription Dosage/Size Total OME < 200 mg | Two sample t-test or Wilcoxon rank-sum test will be used. | Up to 1 year | 
| Percentage of Patients Using Opioids | Two sample t-test or Wilcoxon rank-sum test will be used. | At 30 days after surgery | 
| MDASI-GI in Clinic Visits | Two sample t-test or Wilcoxon rank-sum test will be used. | Up to 1 year | 
| Percentage of Patients Using Opioids | Two sample t-test or Wilcoxon rank-sum test will be used. | At 90 days after surgery | 
| Total OME for First 30 Days and First 90 Days (Inpatient + Outpatient) | Two sample t-test or Wilcoxon rank-sum test will be used. | At 30 and 90 days | 
| Patients and Family Free of Opioid Use | Two sample t-test or Wilcoxon rank-sum test will be used. | At 6 months and 1 year |