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

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ClinicalTrials.gov Identifier: NCT03311737
Recruitment Status : Unknown
Verified September 2017 by Shanghai Zhongshan Hospital.
Recruitment status was:  Recruiting
First Posted : October 17, 2017
Last Update Posted : October 17, 2017
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Single-incision Thoracoscopic Surgery Combination Product: general anesthesia Combination Product: epidural anesthesia Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Compare the Analgesic Effect of Different Anesthesia and Postoperative Analgesic Methods in Uniportal VATS Lung Surgery
Actual Study Start Date : September 19, 2017
Estimated Primary Completion Date : March 31, 2018
Estimated Study Completion Date : March 31, 2018
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. visual analogue scale（VAS） [ Time Frame: 1 year ]
    This scale mainly reflects the patient's pain


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03311737


Contacts
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Contact: yi li, Ph.D 13816836628 loulan_queen@163.com
Contact: xiangting li, B.S. 13671864990 524646417@qq.com

Locations
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China, Shanghai
Zhongshan Hospital Recruiting
Shanghai, Shanghai, China, 200032
Contact: yi li, Ph.D    13816836628    loulan_queen@163.com   
Contact: xiangting li, B.S.    13671864990    524646417@qq.com   
Sponsors and Collaborators
Shanghai Zhongshan Hospital
More Information
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Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT03311737    
Other Study ID Numbers: zs20170511
First Posted: October 17, 2017    Key Record Dates
Last Update Posted: October 17, 2017
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
 Neurologic Manifestations
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs