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

Hepatectomy Clinical Trial

Official title:

Effects of Epidural Anesthesia and Analgesia on Postoperative Metabolic, Immune Function and Hemodynamic Changes of Open Liver Resection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01617811
• Other study ID #: 20120530
• Secondary ID: No. 2009R50040
• Status: Completed
• Phase: N/A
• First received: June 5, 2012
• Last updated: June 9, 2012
• Start date: August 2007
• Est. completion date: December 2008

Study information

• Verified date: June 2012
• Source: Sir Run Run Shaw Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• left hemihepatectomy left lateral sectionectomy clinical diagnosis of hepatolithiasis

Exclusion Criteria:

• abnormal coagulation tests diabetes mellitus significant cirrhosis

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Hepatectomy

Intervention

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.

Locations

Country	Name	City	State
China	Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Sir Run Run Shaw Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical outcomes during and after open liver resection	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.	participants will be followed for the duration of hospital stay, an expected average of 4 weeks	Yes
Secondary	Cytokine change in perioperation of open liver resection	Before operation and 0, 3hr, 12hr, 24hr, D3, D5 after operation, serum IL-1ß, IFN-?, IL-4, IL-10 and TGF-ß by microassay.	Before operation, within 5 days after operation	Yes