Effects of Epidural Anesthesia and Analgesia on the Prognosis in Patients Undergoing Pancreatic Cancer Surgery

December 9, 2019 updated by: Changhong Miao, Fudan University

Effects of Epidural Anesthesia and Analgesia on the Prognosis in Patients Undergoing Pancreatic Cancer Surgery: A Multi-center Randomized Controlled Trial

The purpose of this randomized controlled trial is to investigate the effects of epidural anesthesia and analgesia on the overall survival,disease-free survival and recovery in patients undergoing pancreatic cancer surgery. This study will also evaluate the effects of this technique on neuroendocrine, stress and inflammatory response in these patients.

Study Overview

Status

Unknown

Conditions

Study Type

Interventional

Enrollment (Anticipated)

540

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
        • Contact:
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Fudan University Zhongshan Hospital
        • Contact:
      • Shanghai, Shanghai, China, 200040
        • Not yet recruiting
        • Fudan University Huashan Hospital
        • Contact:

Participation Criteria

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Undergoing elective pancreaticoduodenectomy for pancreatic cancer .
  2. ASA statusⅠ-Ⅲ.
  3. 18 years to 80 years (adults).
  4. Able to understand, communicate and sign an informed consent form.

Exclusion Criteria:

  1. Laparoscopic surgery.
  2. Preoperative chemotherapy or radiotherapy.
  3. Pregnancy.
  4. Allergic to any drugs used during the study.
  5. Long-term receiving β-blockers.
  6. Complicated with chronic inflammatory diseases, autoimmune diseases, or long-term receiving glucocorticoids or other immunosuppressants before surgery.
  7. Abnormal coagulation functions (platelet count prior to surgery <100000/ μL , APTT value is more than the normal value, INR > 1.3 or clopidogrel that cannot be discontinued 7 days prior to surgery).
  8. Complicated with severe heart disease (NYHA classification >3), severe renal insufficiency (serum creatinine >1.8mg/dL or receiving renal replacement therapy), severe hepatic disease (Child-Pugh classification

    = C), diabetes (fasting blood glucose not in the range of 3.9-13.8 mmol/L ), or acute infectious diseases (WBC>10000/μL) before surgery.

  9. BMI > 35.
  10. All contraindications to epidural anesthesia and analgesia.
  11. Chronic opiate medication/drug abuse.
  12. Complicated with severe mental illness, cognitive disorder or unable to collaborate during the study.
  13. Refuse to sign an informed consent form.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GEA+PCEA
General anesthesia combined with epidural anesthesia will be performed during surgery and patient-controlled epidural analgesia (PCEA) will be provided after surgery.
Thoracic epidural catheterization will be performed and epidural anesthesia will be maintained with 0.25% ropivacaine during surgery. General anesthesia will be maintained with inhalation (sevoflurane) and muscle relaxants will be administered when considered necessary.
Other Names:
  • General anesthesia combined with epidural anesthesia
Patient-controlled epidural analgesia (0.15% ropivacaine infusion) will be provided after surgery.
Other Names:
  • Patient-controlled epidural analgesia
Other: GA+PCIA
General anesthesia will be performed during surgery and patient-controlled intravenous analgesia (PCIA) will be provided after surgery.
General anesthesia will be maintained with inhalation (sevoflurane) and sufentanil infusion, and muscle relaxants will be administered when considered necessary.
Other Names:
  • General anesthesia
Patient-controlled intravenous analgesia (1ug/ml sufentanil) will be provided after surgery.
Other Names:
  • Patient-controlled intravenous analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: During 2 years after surgery
Defined and calculated as the time from the date of surgery to death related to all reasons
During 2 years after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival (DFS )
Time Frame: During 2 years after surgery
Defined and calculated as the time from the date of surgery to the first time of pancreatic cancer recurrence or metastasis or cancer-related death
During 2 years after surgery
Postoperative pain score and side effects of patient-controlled analgesia
Time Frame: During the first 48 hours after surgery
Assessed with visual analogue score ( 0 is no pain and 10 is the most severe pain)
During the first 48 hours after surgery
Incidence of delirium
Time Frame: During the first 1 week after surgery
Assessed for delirium using the 3D-CAM instrument
During the first 1 week after surgery
Incidence of persistent post-surgical pain (PPSP) after surgery
Time Frame: During 2 years after surgery
Assessed with visual analogue score ( 0 is no pain and 10 is the most severe pain)
During 2 years after surgery
Length of stay in hospital after surgery and total costs after surgery
Time Frame: During the first 30 days after surgery
During the first 30 days after surgery
Return of bowel function
Time Frame: During the first 30 days after surgery
Measured by the time of first flatus
During the first 30 days after surgery
Start of enteral tube feeding
Time Frame: During the first 30 days after surgery
Measured by the time of first enteral tube feeding after surgery
During the first 30 days after surgery
Removal of Perianastomotic drains
Time Frame: During the first 30 days after surgery
During the first 30 days after surgery
Removal of Urinary drainage
Time Frame: During the first 30 days after surgery
During the first 30 days after surgery
Removal of nasogastric tube
Time Frame: During the first 30 days after surgery
During the first 30 days after surgery
Removal of enteral feeding tube
Time Frame: During the first 30 days after surgery
During the first 30 days after surgery
Blood level of neuroendocrine, stress and inflammatory response
Time Frame: During surgery and the first 24 hours after surgery (post-operative day 1)
Changes of blood epinephrine, norepinephrine, cortisol, VEGF, interleukin-6 (IL-6)、interleukin-8 (IL-8), peripheral blood NLR ( neutrophil-lymphocyte ratio)
During surgery and the first 24 hours after surgery (post-operative day 1)
Serum CA19-9 、CA125、CEA、CA72-4、CA242、AFP、CA15-3、CA50 levels
Time Frame: During 2 years after surgery
During 2 years after surgery
Plasma levels of ropivacaine and sufentanil
Time Frame: During surgery and the first 24 hours after surgery (post-operative day 1)
During surgery and the first 24 hours after surgery (post-operative day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Changhong Miao, Fudan University
  • Study Director: Qianjin Liu, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

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 Major Dates

Study Start (Actual)

December 19, 2017

Primary Completion (Anticipated)

December 18, 2021

Study Completion (Anticipated)

December 18, 2021

Study Registration Dates

First Submitted

August 2, 2017

First Submitted That Met QC Criteria

August 7, 2017

First Posted (Actual)

August 10, 2017

Study Record Updates

Last Update Posted (Actual)

December 11, 2019

Last Update Submitted That Met QC Criteria

December 9, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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