Analgesia and Pancreatic Cancer Surgery

National Taiwan University

Status: Completed

Conditions: Pancreatic Neoplasms

Treatments: Drug: Intravenous patient controlled analgesia; Procedure: Epidural patient controlled analgesia

Study type: Interventional

Funder types: Other

Identifiers

NCT01929915

201203094RIC

Details and patient eligibility

About

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.

Enrollment: 135 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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135 participants in 2 patient groups

Epidural patient controlled analgesia

Active Comparator group

Description:

Epidural patient controlled analgesia

Treatment:

Procedure: Epidural patient controlled analgesia

Intravenous patient controlled analgesia

Sham Comparator group

Description:

Intravenous patient controlled analgesia for post operative pain control

Treatment:

Drug: Intravenous patient controlled analgesia