Cancer of PancreasPhase 1E-PRO INCT02681796
Epidural Analgesia Use in Pancreatic Resections
A Phase 1 study testing Bupivacaine in people with Cancer of Pancreas and Cancer of the Pancreas, run by Washington University School of Medicine at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Pancreas, Cancer of the Pancreas, Pancreas Cancer
- What is being tested?
- Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2016to 7 Feb 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing pancreatic resection.
- Age ≥18 years old.
- Able to understand and sign an Institutional Review Board (IRB)-approved informed consent form.
Who cannot join
- Indication for operative intervention being chronic pancreatitis.
- Currently on warfarin with an INR≥1.4 or clopidogrel that cannot be discontinued 7 days prior to surgery;
- Most recent INR prior to surgery >1.4
- Most recent platelet count prior to surgery <70,000/mcl
- Chronic opioid use as defined by use of more than 20mg oxycodone, or equivalent, daily.
- History of pre-existing neuropathic pain conditions.
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- Not giving consent for study participation.
- Known medical history of significant psychiatric or cognitive impairment
- History of HIV, Hepatitis B, and/or Hepatitis C
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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.
- Conditions
- Cancer of Pancreas, Cancer of the Pancreas, Pancreas Cancer, Pancreas Neoplasms, Pancreatic Cancer
- Being tested
- Bupivacaine
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
| Study group | Role | What they receive |
|---|---|---|
| Study: Bupivacaine Epidural + standard of care pain regimen | Experimental | -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 Receives: Drug: Bupivacaine |
| Control: Standard of care pain regimen | No intervention | -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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: First 72 hours after surgery
Secondary outcomes (14)
Effect of epidural analgesia during the initial post-operative period as measured by total intraoperative fluid volume
Measured: 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
Measured: Up to 6 weeks post-surgery
Benefit of epidural analgesia as measured by time to tumor recurrence
Measured: Up to 2 years post surgery
Benefit of epidural analgesia as measured by disease-free survival
Measured: Up to 2 years post surgery
Benefit of epidural analgesia as measured by overall survival
Measured: 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
Measured: First 72 hours after surgery
Effect of epidural analgesia during the initial post-operative period as measured by total post-operative fluid volume
Measured: Up to 72 hours post surgery
Effect of epidural analgesia during the initial post-operative period as measured by volume of fluid boluses
Measured: Up to 72 hours post surgery
Effect of epidural analgesia during the initial post-operative period as measured by amount of antiemetic doses
Measured: 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
Measured: Up to 72 hours post surgery
Effect of epidural analgesia during the initial post-operative period as measured by first bowel movement
Measured: Up to 72 hours post surgery
Effect of epidural analgesia during the initial post-operative period as measured by length of hospital stay
Measured: 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
Measured: 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
Measured: Up to 6 weeks post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2016 (estimated)
- Study start7 Jun 2016
- Primary completion7 Feb 2020
- Study completion7 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer of PancreasStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Bottros, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02681796
- Sponsor's protocol ID
- 201506125
- Acronym
- E-PRO I
- Status last verified
- Mar 2020
- First submitted
- 10 Feb 2016
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pak LM, Haroutounian S, Hawkins WG, Worley L, Kurtz M, Frey K, Karanikolas M, Swarm RA, Bottros MM. Epidurals in Pancreatic Resection Outcomes (E-PRO) study: protocol for a randomised controlled trial. BMJ Open. 2018 Jan 26;8(1):e018787. doi: 10.1136/bmjopen-2017-018787.
PubMed 29374667
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidural Analgesia Use in Pancreatic Resections
- ClinicalTrials.gov ID
- NCT02681796
- Acronym / sponsor ID
- E-PRO I / 201506125
- Conditions
- Cancer of Pancreas, Cancer of the Pancreas, Pancreas Cancer, Pancreas Neoplasms, Pancreatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 7 Jun 2016 (actual)
- Primary completion
- 7 Feb 2020 (actual)
- Study completion
- 7 Feb 2020 (actual)
- First posted
- 12 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study: Bupivacaine Epidural + standard of care pain regimen | Experimental | Drug: Bupivacaine-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 |
| Control: Standard of care pain regimen | No intervention | –-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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Undergoing pancreatic resection.
- Age ≥18 years old.
- Able to understand and sign an Institutional Review Board (IRB)-approved informed consent form.
Key exclusion criteria (9 listed)
- Indication for operative intervention being chronic pancreatitis.
- Currently on warfarin with an INR≥1.4 or clopidogrel that cannot be discontinued 7 days prior to surgery;
- Most recent INR prior to surgery >1.4
- Most recent platelet count prior to surgery <70,000/mcl
- Chronic opioid use as defined by use of more than 20mg oxycodone, or equivalent, daily.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine | Drug | Study: Bupivacaine Epidural + standard of care pain regimen |
Primary outcome
Total consumption of morphine or morphine-equivalent in patients undergoing pancreatic resections in the control group compared with the study group
Time frame: First 72 hours after surgery
-Will be assessed every 24 hours
14 secondary outcomes
Effect of epidural analgesia during the initial post-operative period as measured by total intraoperative fluid volume
Time frame: During surgery
Benefit of epidural analgesia as measured by the reduction of persistent post-surgical pain (PPSP) after the operation
Time frame: Up to 6 weeks post-surgery
Benefit of epidural analgesia as measured by time to tumor recurrence
Time frame: Up to 2 years post surgery
Benefit of epidural analgesia as measured by disease-free survival
Time frame: Up to 2 years post surgery
Benefit of epidural analgesia as measured by overall survival
Time frame: Up to 2 years post surgery
Rate of delirium in the control group compared with the study group
Time frame: First 72 hours after surgery
Effect of epidural analgesia during the initial post-operative period as measured by total post-operative fluid volume
Time frame: Up to 72 hours post surgery
Effect of epidural analgesia during the initial post-operative period as measured by volume of fluid boluses
Time frame: Up to 72 hours post surgery
Effect of epidural analgesia during the initial post-operative period as measured by amount of antiemetic doses
Time frame: 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
Time frame: Up to 72 hours post surgery
Effect of epidural analgesia during the initial post-operative period as measured by first bowel movement
Time frame: Up to 72 hours post surgery
Effect of epidural analgesia during the initial post-operative period as measured by length of hospital stay
Time frame: 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
Time frame: 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
Time frame: Up to 6 weeks post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
- Derived from this study: PubMed 29374667Pak LM, Haroutounian S, Hawkins WG, Worley L, Kurtz M, Frey K, Karanikolas M, Swarm RA, Bottros MM. Epidurals in Pancreatic Resection Outcomes (E-PRO) study: protocol for a randomised controlled trial. BMJ Open. 2018 Jan 26;8(1):e018787. doi: 10.1136/bmjopen-2017-018787.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Bottros, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bupivacaine in people with Cancer of Pancreas and Cancer of the Pancreas, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total consumption of morphine or morphine-equivalent in patients undergoing pancreatic resections in the control group compared with the study group (time frame: First 72 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02681796, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2020.