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

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: Postoperative Pain; Single-incision Thoracoscopic Surgery
• Intervention / Treatment: Combination product: general anesthesia; Combination product: epidural anesthesia

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

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Zhongshan Hospital
      • Contact: yi li, Ph.D; Phone Number: 13816836628; Email: loulan_queen@163.com
      • Contact: xiangting li, B.S.; Phone Number: 13671864990; Email: 524646417@qq.com

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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）	This scale mainly reflects the patient's pain	1 year

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

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: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• 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