Compare the Analgesic Effect of Different Anesthesia and Postoperative Analgesic Methods in Uniportal VATS Lung Surgery (CDAAMIUVLS)

October 14, 2017 updated by: Shanghai Zhongshan Hospital
This is a single center, randomized, single blind study to compare the analgesic effect of different anesthesia and postoperative analgesic methods in uniportal VATS lung surgery.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Combining epidural with general anesthesia is regarded as the gold standard of general thoracic surgery. The uniportal VATS lung surgery have advantages of minimal invasive surgical incision, less postoperative pain, and so on. Whether general anesthesia can become an alternative method of combining epidural with general anesthesia in uniportal VATS lung surgery, investigators thus plan to make a comparison on intraoperative stress response, postoperative pain, immune function of patients，and hospital expenses.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • ZhongShan Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients elective uniportal VATS lung surgery;
  • BMI 18-30 kg/m2.

Exclusion Criteria:

  • Patient refuse;
  • ASA≥3;
  • Patients allergic to use anesthetics (propofol,rocuronium), patients with liver and/or kidney and/or mental dysfunction.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: general anesthesia group
The patients in this group receive general anesthesia preoperatively, and use patient controlled intravenous analgesia postoperatively.
Combination product: general anesthesia
The investigators used general anesthesia preoperatively in uniportal VATS lung surgery
Active Comparator: epidural group
The patients in this group receive general anesthesia combined with epidural anesthesia, and use patient controlled epidural analgesia postoperatively.
Combination product: epidural anesthesia
The investigators used general anesthesia combined with epidural anesthesia preoperatively in uniportal VATS lung surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visual analogue scale（VAS）
Time Frame: 1 year
This scale mainly reflects the patient's pain
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 19, 2017

Primary Completion (Anticipated)

March 31, 2018

Study Completion (Anticipated)

March 31, 2018

Study Registration Dates

First Submitted

September 23, 2017

First Submitted That Met QC Criteria

October 14, 2017

First Posted (Actual)

October 17, 2017

Study Record Updates

Last Update Posted (Actual)

October 17, 2017

Last Update Submitted That Met QC Criteria

October 14, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • zs20170511

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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