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

Fudan University

Status: Unknown

Conditions: Cancer of Pancreas

Treatments: Drug: PCEA; Drug: PCIA; Drug: GA; Drug: GEA

Study type: Interventional

Funder types: Other

Identifiers

NCT03245346

FDUSCCA-1

Details and patient eligibility

About

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.

Enrollment: 540 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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540 participants in 2 patient groups

GEA+PCEA

Experimental group

Description:

General anesthesia combined with epidural anesthesia will be performed during surgery and patient-controlled epidural analgesia (PCEA) will be provided after surgery.

Treatment:

Drug: GEA

Drug: PCEA

GA+PCIA

Other group

Description:

General anesthesia will be performed during surgery and patient-controlled intravenous analgesia (PCIA) will be provided after surgery.

Treatment:

Drug: GA

Drug: PCIA