Repeat Quadratus Lumborum Block to Reduce Opioid Need in Patients After Pancreatic Surgery
NCT ID: NCT03745794
Last Updated: 2025-12-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
136 participants
INTERVENTIONAL
2019-02-28
2025-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Arm I (QL block, standard of care)
Patients undergo QL block before surgery and receive standard of care multimodal pain control after surgery.
Best Practice
Given standard of care
Quadratus Lumborum Block
Undergo QL block
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Arm II (second 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.
Best Practice
Given standard of care
Quadratus Lumborum Block
Undergo QL block
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
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Best Practice
Given standard of care
Quadratus Lumborum Block
Undergo QL block
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Laparoscopic or minimally invasive surgery.
18 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Ching-Wei D Tzeng
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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MD Anderson Cancer Center
Other Identifiers
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NCI-2018-02182
Identifier Type: REGISTRY
Identifier Source: secondary_id
2018-0519
Identifier Type: OTHER
Identifier Source: secondary_id
2018-0519
Identifier Type: -
Identifier Source: org_study_id