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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-02182 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2018-0519 | Other Identifier | M D Anderson Cancer Center |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (QL block, standard of care) | Active Comparator | Patients undergo QL block before surgery and receive standard of care multimodal pain control after surgery. |
|
| Arm II (second QL block) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Given standard of care |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ching-Wei D Tzeng | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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30 participants were excluded from the study before assignment to arms due to aborted surgery, discharged before 4 days after surgery or opioids free at 3rd day after surgery.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1, Control Arm (Usual Care) | Patients undergo QL block before surgery and receive standard of care multimodal pain control after surgery. |
| FG001 | Arm 2, Experimental Arm (2nd QL-Block) | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1, Control Arm (Usual Care) | Patients undergo QL block before surgery and receive standard of care multimodal pain control after surgery. |
| BG001 | Arm 2, Experimental Arm (2nd QL-Block) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | one participant inevaluable for analysis. | Posted | Count of Participants | Participants | 90 days from surgery |
|
90 days from surgery
All surgical complications for 90 days after the surgery were recorded. They were all unrelated to the QL-Block. The MDASI questionnaire survey were collected from 3/1/2019 to 11/29/2021. All deaths were unrelated to the QL-Block.
In Arm 2, 53 participants were recorded as 1 of the 54 participants dropped out. We were unable to officially track the 90 day outcomes for that participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1, Control Arm (Usual Care) | Patients undergo QL block before surgery and receive standard of care multimodal pain control after surgery. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Delayed Gastric Emptying | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Delayed Gastric Emptying | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ching-Wei D. Tzeng, MD/Associate Professor, Surgical Oncology | UT MD Anderson Cancer Center | (713) 792-0386 | cdtzeng@mdanderson.org |
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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 | Jun 15, 2020 | Nov 29, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 16, 2020 | Aug 8, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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| Quadratus Lumborum Block | Drug | Undergo QL block |
|
|
| Quality-of-Life Assessment | Other | Ancillary studies |
|
|
| Questionnaire Administration | Other | Ancillary studies |
|
| 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 |
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.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Total Inpatient Oral Morphine Equivalents (OME) | Two sample t-test or Wilcoxon rank-sum test will be used. | Not Posted | Jul 2026 | Up to 1 year | Participants |
| Secondary | Hospital Cost | Two sample t-test. | Not Posted | Jul 2026 | Up to 1 year | Participants |
| Secondary | 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. | Not Posted | Jul 2026 | Up to 1 year | Participants |
| Secondary | Pain Prescription Dosage/Size | Two sample t-test or Wilcoxon rank-sum test will be used. | Not Posted | Jul 2026 | through study completion, an average of 1 year | Participants |
| Secondary | 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. | Not Posted | Jul 2026 | Up to 1 year | Participants |
| Secondary | Percentage of Patients Using Opioids | Two sample t-test or Wilcoxon rank-sum test will be used. | Not Posted | Jul 2026 | At 30 days after surgery | Participants |
| Secondary | MDASI-GI in Clinic Visits | Two sample t-test or Wilcoxon rank-sum test will be used. | Not Posted | Jul 2026 | Up to 1 year | Participants |
| Secondary | Percentage of Patients Using Opioids | Two sample t-test or Wilcoxon rank-sum test will be used. | Not Posted | Jul 2026 | At 90 days after surgery | Participants |
| Secondary | Total OME for First 30 Days and First 90 Days (Inpatient + Outpatient) | Two sample t-test or Wilcoxon rank-sum test will be used. | Not Posted | Jul 2026 | At 30 and 90 days | Participants |
| Secondary | Patients and Family Free of Opioid Use | Two sample t-test or Wilcoxon rank-sum test will be used. | Not Posted | Jul 2026 | At 6 months and 1 year | Participants |
| 3 |
| 52 |
| 10 |
| 52 |
| 39 |
| 52 |
| EG001 | Arm 2, Experimental Arm (2nd QL-Block) | 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. | 3 | 54 | 10 | 54 | 31 | 54 |
| Pancreatic leak | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| BJ leak | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Chyle leak | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| GI Other | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Pulmonary Other | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hemorrhage | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hematologic_ other | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Abscess | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Sterile collection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Line infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infectious Other | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Pancreatic leak | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Chyle leak | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| GI Other | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Arrythmia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Edema | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hemorrhage | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Post-op transfusion | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hematologic_ other | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Acute Renal Failure | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Renal other | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Abscess | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Cholangitis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Wound infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Colitis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infectious Other | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Neurologic_Other | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Metabolic Other | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |