Effects of Epidural Anesthesia and Analgesia on the Prognosis in Patients Undergoing Pancreatic Cancer Surgery
NCT ID: NCT03245346
Last Updated: 2019-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
540 participants
INTERVENTIONAL
2017-12-19
2021-12-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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GEA+PCEA
General anesthesia combined with epidural anesthesia will be performed during surgery and patient-controlled epidural analgesia (PCEA) will be provided after surgery.
GEA
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.
PCEA
Patient-controlled epidural analgesia (0.15% ropivacaine infusion) will be provided after surgery.
GA+PCIA
General anesthesia will be performed during surgery and patient-controlled intravenous analgesia (PCIA) will be provided after surgery.
GA
General anesthesia will be maintained with inhalation (sevoflurane) and sufentanil infusion, and muscle relaxants will be administered when considered necessary.
PCIA
Patient-controlled intravenous analgesia (1ug/ml sufentanil) will be provided after surgery.
Interventions
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GEA
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.
PCEA
Patient-controlled epidural analgesia (0.15% ropivacaine infusion) will be provided after surgery.
GA
General anesthesia will be maintained with inhalation (sevoflurane) and sufentanil infusion, and muscle relaxants will be administered when considered necessary.
PCIA
Patient-controlled intravenous analgesia (1ug/ml sufentanil) will be provided after surgery.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. ASA statusⅠ-Ⅲ.
3. 18 years to 80 years （adults）.
4. Able to understand, communicate and sign an informed consent form.
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Washington University School of Medicine
OTHER
Fudan University
OTHER
Responsible Party
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Changhong Miao
Director of Anesthesiology Department of Fudan University Shanghai Cancer Center
Principal Investigators
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Changhong Miao
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Qianjin Liu
Role: STUDY_DIRECTOR
Washington University School of Medicine
Locations
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Fudan University Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Fudan University Huashan Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Changhao Miao
Role: primary
Xuqin Zhu
Role: backup
Jing Cang
Role: primary
Yingwei Wang
Role: primary
References
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Zhang H, Qu M, Guo K, Wang Y, Gu J, Wu H, Zhu X, Sun Z, Cata JP, Chen W, Miao C. Intraoperative lidocaine infusion in patients undergoing pancreatectomy for pancreatic cancer: a mechanistic, multicentre randomised clinical trial. Br J Anaesth. 2022 Aug;129(2):244-253. doi: 10.1016/j.bja.2022.03.031. Epub 2022 Jun 11.
Other Identifiers
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FDUSCCA-1
Identifier Type: -
Identifier Source: org_study_id