Epidural Analgesia Use in Pancreatic Resections

Phase 1

Completed

• Conditions: Pancreas Cancer; Pancreas Neoplasms; Cancer of Pancreas; Pancreatic Cancer; Cancer of the Pancreas
• Interventions: Drug: Bupivacaine

• Registration Number: NCT02681796
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-10
• Study First Submitted QC: 2016-02-10
• Study First Posted: 2016-02-12
• Study Start: 2016-06-07
• Primary Completion: 2020-02-07
• Study Completion: 2020-02-07
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-11
• Last Update Posted: 2020-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study: Bupivacaine Epidural + standard of care pain regimen	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

Primary Outcome Measures

Name	Time	Method
Total consumption of morphine or morphine-equivalent in patients undergoing pancreatic resections in the control group compared with the study group	First 72 hours after surgery	-Will be assessed every 24 hours

Secondary Outcome Measures

Name	Time	Method
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 relative ratios of blood level inflammatory markers	Up to 6 weeks post-surgery	-Specifically interleukin-1-beta (IL-1B), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-a), and interleukin 10 (IL-10) biomarkers
Effect of epidural analgesia during the initial post-operative period as measured by volume of fluid boluses	Up to 72 hours post surgery
Benefit of epidural analgesia as measured by the reduction of persistent post-surgical pain (PPSP) after the operation	Up to 6 weeks post-surgery	-Quantitative sensory testing will be performed on the abdomen in close proximity to the surgical incision
Benefit of epidural analgesia as measured by disease-free survival	Up to 2 years post surgery
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 time to tumor recurrence	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	First 72 hours after surgery	* 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
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 amount of antiemetic doses	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 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 incidence of deep venous thromboembolism/pulmonary embolism	Up to 72 hours post surgery

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States