Effect of Epidural Anesthesia and Analgesia on Patients' Outcomes After Liver Resection
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.
|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|
- 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.
- 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.
|Study Start Date:||August 2007|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01617811
|Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University|
|Hangzhou, Zhejiang, China, 310016|