Clinical Trials Directory

Trials / Completed

CompletedNCT01929915

Analgesia and Pancreatic Cancer Surgery

Perioperative Epidural Analgesia for Short-term and Long-term Outcomes of Pancreatic Cancer Surgery- Randomised Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
135 (actual)
Sponsor
National Taiwan University Hospital · Academic / Other
Sex
All
Age
20 Years – 85 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREEpidural patient controlled analgesiaPatient controlled epidural analgesia with marcaine(1mg/ml)+ fentanyl(1.25mcg/ml)for postoperative pain control
DRUGIntravenous patient controlled analgesiaIntravenous patient controlled analgesia with morphine(1mg/ml)for post operative pain control

Timeline

Start date
2013-07-01
Primary completion
2015-04-01
Completion
2015-04-01
First posted
2013-08-28
Last updated
2022-05-11

Locations

1 site across 1 country: Taiwan

Source: ClinicalTrials.gov record NCT01929915. Inclusion in this directory is not an endorsement.