Epidural Analgesia Use in Pancreatic Resections

Pancreatic Cancer Clinical Trial

— E-PRO I  

Official title:

Epidural Analgesia Use in Pancreatic Resections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02681796
• Other study ID #: 201506125
• Status: Completed
• Phase: Phase 1
• Start date: June 7, 2016
• Est. completion date: February 7, 2020

Study information

• Verified date: March 2020
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: February 7, 2020
• Est. primary completion date: February 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer of Pancreas
• Cancer of the Pancreas
• Pancreas Cancer
• Pancreas Neoplasms
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Bupivacaine

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Effect of epidural analgesia during the initial post-operative period as measured by total intraoperative fluid volume		During surgery
Secondary	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
Secondary	Benefit of epidural analgesia as measured by time to tumor recurrence		Up to 2 years post surgery
Secondary	Benefit of epidural analgesia as measured by disease-free survival		Up to 2 years post surgery
Secondary	Benefit of epidural analgesia as measured by overall survival		Up to 2 years post surgery
Secondary	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
Secondary	Effect of epidural analgesia during the initial post-operative period as measured by total post-operative fluid volume		Up to 72 hours post surgery
Secondary	Effect of epidural analgesia during the initial post-operative period as measured by volume of fluid boluses		Up to 72 hours post surgery
Secondary	Effect of epidural analgesia during the initial post-operative period as measured by amount of antiemetic doses		Up to 72 hours post surgery
Secondary	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
Secondary	Effect of epidural analgesia during the initial post-operative period as measured by first bowel movement		Up to 72 hours post surgery
Secondary	Effect of epidural analgesia during the initial post-operative period as measured by length of hospital stay		Up to 2 weeks post surgery
Secondary	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
Secondary	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

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine