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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chun-Yan Yan, Sir Run Run Shaw Hospital
ClinicalTrials.gov Identifier:
NCT01617811
First received: June 5, 2012
Last updated: June 9, 2012
Last verified: June 2012
  Purpose

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
Hepatectomy
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • left hemihepatectomy left lateral sectionectomy clinical diagnosis of hepatolithiasis

Exclusion Criteria:

  • abnormal coagulation tests diabetes mellitus significant cirrhosis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01617811

Locations
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

No publications provided

Responsible Party: Chun-Yan Yan, M.D. , Ph.D, Sir Run Run Shaw Hospital
ClinicalTrials.gov 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:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 16, 2014