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

• Sponsor: Shanghai Zhongshan Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03311737
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 6.3
• Patients Per Site Per Month: 15.8

Study Details

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.

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

• Study Type: Interventional
• Anticipated 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: Sep 19, 2017
• Anticipated Primary Completion Date: Mar 31, 2018
• Anticipated Study Completion Date: Mar 31, 2018

Arms and Interventions

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

Primary Outcome Measures

1. visual analogue scale（VAS） [1 year]

   This scale mainly reflects the patient's pain

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Zhongshan Hospital	Shanghai	Shanghai	China	200032

Sponsors and Collaborators

• Shanghai Zhongshan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shanghai Zhongshan Hospital
• ClinicalTrials.gov Identifier: NCT03311737
• Other Study ID Numbers: zs20170511
• First Posted: Oct 17, 2017
• Last Update Posted: Oct 17, 2017
• Last Verified: Sep 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pain, Postoperative; Anesthetics

Study Results

No Results Posted as of Oct 17, 2017