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Effect of Epidural Anesthesia and Analgesia on Patients' Outcomes After Liver Resection

This study has been completed.
Information provided by (Responsible Party):
Chun-Yan Yan, Sir Run Run Shaw Hospital Identifier:
First received: June 5, 2012
Last updated: June 9, 2012
Last verified: June 2012
The purpose of this study is to analyze the effects of epidural anesthesia and analgesia on intraoperative clinical outcome, postoperative recovery, metabolic changes, and immune functions of the patients receiving open liver resection.

Condition Intervention
Procedure: epidural anesthesia and analgesia

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Effects of Epidural Anesthesia and Analgesia on Postoperative Metabolic, Immune Function and Hemodynamic Changes of Open Liver Resection

Further study details as provided by Sir Run Run Shaw Hospital:

Primary Outcome Measures:
  • Clinical outcomes during and after open liver resection [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ] [ Designated as safety issue: Yes ]

    intraoperative outcome including operation time, liver resection time, estimated blood loss, urine output, etc during operation. PACU recovery, pain score, liver and gastrointestinal function, hospital stay time,etc assessed.

    Before operation, right after operation(0), and 3hr, 12hr, 24hr, 72hrs after operation, blood glucose and insulin was measured.

Secondary Outcome Measures:
  • Cytokine change in perioperation of open liver resection [ Time Frame: Before operation, within 5 days after operation ] [ Designated as safety issue: Yes ]
    Before operation and 0, 3hr, 12hr, 24hr, D3, D5 after operation, serum IL-1β, IFN-γ, IL-4, IL-10 and TGF-β by microassay.

Enrollment: 26
Study Start Date: August 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: epidural anesthesia and analgesia

    A thoracic epidural catheter (T8-10) was placed in group E. A bolus of 8ml 1% lidocaine with 0.375% ropivacaine was administered 15min before skin incision, followed by 5-8 ml/hr infusion during surgery in group E.

    Postoperative analgesia by PCEA in group E (concentration: 0.1% ropivacaine + 0.1μg/ml sufentanil, loading dose: 4ml, infusion rate: 8ml/hr, bolus: 4ml, 1hr limit: 16ml) and lasting for 48hr and PCIA in group G (concentration: 1μg/ml sufentanil, loading dose: 4ml, bolus: 2ml, 4hr limit: 30ml).

    Both group received general anesthesia maintaining with 1-2% end tidal sevoflurane together with TCI of propofol (target plasma concentration, 2-3µg/ml), continuous infusion of remifentanil (0.10 - 0.20 μg/kg/min) and cis-atracurium intermittently as needed.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • left hemihepatectomy left lateral sectionectomy clinical diagnosis of hepatolithiasis

Exclusion Criteria:

  • abnormal coagulation tests diabetes mellitus significant cirrhosis
  Contacts and Locations
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Please refer to this study by its identifier: NCT01617811

China, Zhejiang
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310016
Sponsors and Collaborators
Sir Run Run Shaw Hospital
  More Information

Responsible Party: Chun-Yan Yan, M.D. , Ph.D, Sir Run Run Shaw Hospital Identifier: NCT01617811     History of Changes
Other Study ID Numbers: 20120530  No. 2009R50040 
Study First Received: June 5, 2012
Last Updated: June 9, 2012
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Central Nervous System Depressants
Physiological Effects of Drugs processed this record on October 21, 2016