Analgesia and Pancreatic Cancer Surgery

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2015-04-30

Brief Summary

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Long-term survival for patients with pancreatic carcinoma is low, even following resection, the 5-year survival rate of patients ranges from 10 to 25%1. Most treatment failure is due to local recurrence, distant metastasis or both within one to two years after surgery2-4.

Surgery has been suggested to accelerate the development of preexisting micro metastases and to promote the establishment of new metastases5. Release of catecholamine and proinflammatory products secondary to surgical stress is believed to promote cancer progression6. Maintenance of proper anesthetic depth is beneficial to attenuate surgical stress. However, general anesthesia including numerous induction agents, volatile anesthetics and opioids, is associated with immunosuppression especially on the cell-mediated immunity which has a crucial role in prevention of micrometastasis5,7. Therefore, regional anesthesia and analgesia which effectively attenuating surgical stress while efficiently reducing general anesthetics consumption, seem to provide promising advantages to prevent perioperative cancer progression. Currently, most studies available in humans are retrospective and observational to evaluate regional anesthesia and prostate, colorectal, breast and cervical cancer-related outcomes8-12. Only one randomized study investigating major abdominal cancer surgery is available13. However, it is not specific to an individual cancer type and perioperative cell-mediated immunity is not evaluated.

In this study, we aimed to identify whether epidural block beneficial to early surgical and late cancer-related outcomes in patients receiving pancreatic cancer surgery. Perioperative cell-mediated immunity functions including natural killer cells, helper and cytotoxic T-lymphocytes were also investigated.

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Detailed Description

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Conditions

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Pancreatic Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Epidural patient controlled analgesia

Group Type ACTIVE_COMPARATOR

Epidural patient controlled analgesia

Intervention Type PROCEDURE

Patient controlled epidural analgesia with marcaine(1mg/ml)+ fentanyl(1.25mcg/ml)for postoperative pain control

Intravenous patient controlled analgesia

Intravenous patient controlled analgesia for post operative pain control

Group Type SHAM_COMPARATOR

Intravenous patient controlled analgesia

Intervention Type DRUG

Intravenous patient controlled analgesia with morphine(1mg/ml)for post operative pain control

Interventions

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Epidural patient controlled analgesia

Patient controlled epidural analgesia with marcaine(1mg/ml)+ fentanyl(1.25mcg/ml)for postoperative pain control

Intervention Type PROCEDURE

Intravenous patient controlled analgesia

Intravenous patient controlled analgesia with morphine(1mg/ml)for post operative pain control

Intervention Type DRUG

Other Intervention Names

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Fentanyl marcaine(bupivacaine hydrochloride) morphine

Eligibility Criteria

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Inclusion Criteria

* Pancreatic cancer expected to receive curative Whipple operation

Exclusion Criteria

* palliative operation
* preoperative chemotherapy or radiotherapy
* patients with metastasis
* contraindications for epidural catheter placement
* prior spine surgery

Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No