2019-02-28
2021-11-29
2023-03-31
136
NCT03745794
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
INTERVENTIONAL
Repeat Quadratus Lumborum Block to Reduce Opioid Need in Patients After Pancreatic Surgery
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2018-11-14 | 2022-11-29 | 2023-02-08 |
2018-11-15 | 2023-02-08 | 2023-02-13 |
2018-11-19 | 2023-02-13 | 2022-11 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Triple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: Arm I (QL block, standard of care) Patients undergo QL block before surgery and receive standard of care multimodal pain control after surgery. | OTHER: Best Practice
DRUG: Quadratus Lumborum Block
OTHER: Quality-of-Life Assessment
OTHER: Questionnaire Administration
|
| EXPERIMENTAL: 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. | OTHER: Best Practice
DRUG: Quadratus Lumborum Block
OTHER: Quality-of-Life Assessment
OTHER: Questionnaire Administration
|
| Primary Outcome Measures | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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