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2016-06-07
2020-02-07
2020-02-07
23
NCT02681796
Washington University School of Medicine
Washington University School of Medicine
INTERVENTIONAL
Epidural Analgesia Use in Pancreatic Resections
The rationale for this study is to investigate the benefits of epidural analgesia in pancreatic resections in a prospective, single blind, randomized control trial. This study will evaluate both short and long-term outcomes related to epidural analgesia, providing a longitudinal and comprehensive perspective to the advantages and disadvantages of this technique. The investigators hypothesize that the use of epidural analgesia reduces a patient's consumption of morphine or morphine-equivalent in the post-operative period following pancreatic resections.
N/A
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 |
|---|---|---|
2016-02-10 | N/A | 2020-03-11 |
2016-02-10 | N/A | 2020-03-12 |
2016-02-12 | N/A | 2020-03 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Supportive Care
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Study: Bupivacaine Epidural + standard of care pain regimen -The study group will receive a T6 to T8 level epidural catheter in addition to the standardized pain regimen. Epidurals used in this study will contain a 0.125% bupivacaine-only infusion | DRUG: Bupivacaine |
| NO_INTERVENTION: Control: Standard of care pain regimen -The control group will receive a standardized pain regimen including an opioid patient controlled analgesia (PCA), IV acetaminophen, and IV ketorolac per surgeon's preference |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Total consumption of morphine or morphine-equivalent in patients undergoing pancreatic resections in the control group compared with the study group | -Will be assessed every 24 hours | First 72 hours after surgery |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Effect of epidural analgesia during the initial post-operative period as measured by total intraoperative fluid volume | During surgery | |
| Benefit of epidural analgesia as measured by the reduction of persistent post-surgical pain (PPSP) after the operation | -Quantitative sensory testing will be performed on the abdomen in close proximity to the surgical incision | Up to 6 weeks post-surgery |
| Benefit of epidural analgesia as measured by time to tumor recurrence | Up to 2 years post surgery | |
| Benefit of epidural analgesia as measured by disease-free survival | Up to 2 years post surgery | |
| Benefit of epidural analgesia as measured by overall survival | Up to 2 years post surgery | |
| Rate of delirium in the control group compared with the study group | * Assessed for delirium using the 3D-CAM instrument * Postoperative delirium assessments will be performed when patients can be around sufficiently in order to be assessed for delirium using the Richmond-Agitation-Sedation Scale. * Will be assessed for delirium once daily in the afternoon/evening | First 72 hours after surgery |
| Effect of epidural analgesia during the initial post-operative period as measured by total post-operative fluid volume | Up to 72 hours post surgery | |
| Effect of epidural analgesia during the initial post-operative period as measured by volume of fluid boluses | Up to 72 hours post surgery | |
| Effect of epidural analgesia during the initial post-operative period as measured by amount of antiemetic doses | Up to 72 hours post surgery | |
| Effect of epidural analgesia during the initial post-operative period as measured by return of bowel function by time to first flatus | Up to 72 hours post surgery | |
| Effect of epidural analgesia during the initial post-operative period as measured by first bowel movement | Up to 72 hours post surgery | |
| Effect of epidural analgesia during the initial post-operative period as measured by length of hospital stay | Up to 2 weeks post surgery | |
| Effect of epidural analgesia during the initial post-operative period as measured by incidence of deep venous thromboembolism/pulmonary embolism | Up to 72 hours post surgery | |
| Effect of epidural analgesia during the initial post-operative period as measured by relative ratios of blood level inflammatory markers | -Specifically interleukin-1-beta (IL-1B), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-a), and interleukin 10 (IL-10) biomarkers | Up to 6 weeks post-surgery |
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
