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

Not Applicable

• Conditions: Cancer of Pancreas
• Interventions: Drug: GEA; Drug: GA; Drug: PCIA; Drug: PCEA

• Registration Number: NCT03245346
• Lead Sponsor: Fudan University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-02
• Study First Submitted QC: 2017-08-07
• Study First Posted: 2017-08-10
• Study Start: 2017-12-19
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-09
• Last Update Posted: 2019-12-11
• Primary Completion: 2021-12-18
• Study Completion: 2021-12-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 540

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GEA+PCEA	GEA	General anesthesia combined with epidural anesthesia will be performed during surgery and patient-controlled epidural analgesia (PCEA) will be provided after surgery.
GA+PCIA	GA	General anesthesia will be performed during surgery and patient-controlled intravenous analgesia (PCIA) will be provided after surgery.
GA+PCIA	PCIA	General anesthesia will be performed during surgery and patient-controlled intravenous analgesia (PCIA) will be provided after surgery.
GEA+PCEA	PCEA	General anesthesia combined with epidural anesthesia will be performed during surgery and patient-controlled epidural analgesia (PCEA) will be provided after surgery.

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	During 2 years after surgery	Defined and calculated as the time from the date of surgery to death related to all reasons

Secondary Outcome Measures

Name	Time	Method
Serum CA19-9 、CA125、CEA、CA72-4、CA242、AFP、CA15-3、CA50 levels	During 2 years after surgery
Incidence of delirium	During the first 1 week after surgery	Assessed for delirium using the 3D-CAM instrument
Removal of Perianastomotic drains	During the first 30 days after surgery
Incidence of persistent post-surgical pain (PPSP) after surgery	During 2 years after surgery	Assessed with visual analogue score ( 0 is no pain and 10 is the most severe pain)
Return of bowel function	During the first 30 days after surgery	Measured by the time of first flatus
Removal of Urinary drainage	During the first 30 days after surgery
Length of stay in hospital after surgery and total costs after surgery	During the first 30 days after surgery
Removal of enteral feeding tube	During the first 30 days after surgery
Blood level of neuroendocrine, stress and inflammatory response	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)
Postoperative pain score and side effects of patient-controlled analgesia	During the first 48 hours after surgery	Assessed with visual analogue score ( 0 is no pain and 10 is the most severe pain)
Removal of nasogastric tube	During the first 30 days after surgery
Disease-free survival (DFS )	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
Start of enteral tube feeding	During the first 30 days after surgery	Measured by the time of first enteral tube feeding after surgery
Plasma levels of ropivacaine and sufentanil	During surgery and the first 24 hours after surgery (post-operative day 1)

Trial Locations

Locations (3)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China

Fudan University Huashan Hospital; 🇨🇳 Shanghai, Shanghai, China

Fudan University Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China