Clinical trial NCT02681796: Epidural Analgesia Use in Pancreatic Resections
Official title: Epidural Analgesia Use in Pancreatic Resections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer of Pancreas
Cancer of the Pancreas
Pancreas Cancer
Pancreas Neoplasms
Pancreatic Cancer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2016-02-12
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* Undergoing pancreatic resection.
* Age ≥18 years old.
* Able to understand and sign an Institutional Review Board (IRB)-approved informed consent form.

Exclusion Criteria:

* 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.
* Not giving consent for study participation.
* Known medical history of significant psychiatric or cognitive impairment
* History of HIV, Hepatitis B, and/or Hepatitis C

Primary outcomes:
measure: Total consumption of morphine or morphine-equivalent in patients undergoing pancreatic resections in the control group compared with the study group
timeFrame: First 72 hours after surgery
Secondary outcomes:
measure: Effect of epidural analgesia during the initial post-operative period as measured by total intraoperative fluid volume
timeFrame: During surgery
measure: Benefit of epidural analgesia as measured by the reduction of persistent post-surgical pain (PPSP) after the operation
timeFrame: Up to 6 weeks post-surgery
measure: Benefit of epidural analgesia as measured by time to tumor recurrence
timeFrame: Up to 2 years post surgery
measure: Benefit of epidural analgesia as measured by disease-free survival
timeFrame: Up to 2 years post surgery
measure: Benefit of epidural analgesia as measured by overall survival
timeFrame: Up to 2 years post surgery
measure: Rate of delirium in the control group compared with the study group
timeFrame: First 72 hours after surgery
measure: Effect of epidural analgesia during the initial post-operative period as measured by total post-operative fluid volume
timeFrame: Up to 72 hours post surgery
measure: Effect of epidural analgesia during the initial post-operative period as measured by volume of fluid boluses
timeFrame: Up to 72 hours post surgery
measure: Effect of epidural analgesia during the initial post-operative period as measured by amount of antiemetic doses
timeFrame: Up to 72 hours post surgery
measure: Effect of epidural analgesia during the initial post-operative period as measured by return of bowel function by time to first flatus
timeFrame: Up to 72 hours post surgery
measure: Effect of epidural analgesia during the initial post-operative period as measured by first bowel movement
timeFrame: Up to 72 hours post surgery
measure: Effect of epidural analgesia during the initial post-operative period as measured by length of hospital stay
timeFrame: Up to 2 weeks post surgery
measure: Effect of epidural analgesia during the initial post-operative period as measured by incidence of deep venous thromboembolism/pulmonary embolism
timeFrame: Up to 72 hours post surgery
measure: Effect of epidural analgesia during the initial post-operative period as measured by relative ratios of blood level inflammatory markers
timeFrame: Up to 6 weeks post-surgery
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Michael Bottros, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.