Back to resultsCompare the Analgesic Effect of Different Anesthesia and Postoperative Analgesic Methods in Uniportal VATS Lung Surgery (CDAAMIUVLS)
Primary Purpose
Postoperative Pain, Single-incision Thoracoscopic Surgery
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
general anesthesia
epidural anesthesia
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Pain
Eligibility Criteria
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.
Sites / Locations
- Zhongshan HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
general anesthesia group
epidural group
Arm Description
The patients in this group receive general anesthesia preoperatively, and use patient controlled intravenous analgesia postoperatively.
The patients in this group receive general anesthesia combined with epidural anesthesia, and use patient controlled epidural analgesia postoperatively.
Outcomes
Primary Outcome Measures
visual analogue scale（VAS）
This scale mainly reflects the patient's pain
Secondary Outcome Measures
Full Information
NCT ID
NCT03311737
First Posted
September 23, 2017
Last Updated
October 14, 2017
Sponsor
Shanghai Zhongshan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03311737
Brief Title
Compare the Analgesic Effect of Different Anesthesia and Postoperative Analgesic Methods in Uniportal VATS Lung Surgery
Acronym
CDAAMIUVLS
Official Title
Compare the Analgesic Effect of Different Anesthesia and Postoperative Analgesic Methods in Uniportal VATS Lung Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 19, 2017 (Actual)
Primary Completion Date
March 31, 2018 (Anticipated)
Study Completion Date
March 31, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Zhongshan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Single-incision Thoracoscopic Surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
general anesthesia group
Arm Type
Experimental
Arm Description
The patients in this group receive general anesthesia preoperatively, and use patient controlled intravenous analgesia postoperatively.
Arm Title
epidural group
Arm Type
Active Comparator
Arm Description
The patients in this group receive general anesthesia combined with epidural anesthesia, and use patient controlled epidural analgesia postoperatively.
Intervention Type
Combination Product
Intervention Name(s)
general anesthesia
Intervention Description
The investigators used general anesthesia preoperatively in uniportal VATS lung surgery
Intervention Type
Combination Product
Intervention Name(s)
epidural anesthesia
Intervention Description
The investigators used general anesthesia combined with epidural anesthesia preoperatively in uniportal VATS lung surgery
Primary Outcome Measure Information:
Title
visual analogue scale（VAS）
Description
This scale mainly reflects the patient's pain
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
yi li, Ph.D
Phone
13816836628
Email
loulan_queen@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
xiangting li, B.S.
Phone
13671864990
Email
524646417@qq.com
Facility Information:
Facility Name
Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yi li, Ph.D
Phone
13816836628
Email
loulan_queen@163.com
First Name & Middle Initial & Last Name & Degree
xiangting li, B.S.
Phone
13671864990
Email
524646417@qq.com
12. IPD Sharing Statement
Learn more about this trial
Compare the Analgesic Effect of Different Anesthesia and Postoperative Analgesic Methods in Uniportal VATS Lung Surgery
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