NCT03311737

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for phase_1 postoperative-pain

Timeline
Completed

Started Sep 2017

Shorter than P25 for phase_1 postoperative-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 19, 2017

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2017

Completed
24 days until next milestone

First Posted

Study publicly available on registry

October 17, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
Last Updated

October 17, 2017

Status Verified

September 1, 2017

Enrollment Period

6 months

First QC Date

September 23, 2017

Last Update Submit

October 14, 2017

Conditions

Postoperative PainSingle-incision Thoracoscopic Surgery

Outcome Measures

Primary Outcomes (1)

  • visual analogue scale（VAS）

    This scale mainly reflects the patient's pain

    1 year

Study Arms (2)

general anesthesia group

EXPERIMENTAL

The patients in this group receive general anesthesia preoperatively, and use patient controlled intravenous analgesia postoperatively.

Combination Product: general anesthesia

epidural group

ACTIVE COMPARATOR

The patients in this group receive general anesthesia combined with epidural anesthesia, and use patient controlled epidural analgesia postoperatively.

Combination Product: epidural anesthesia

Interventions

general anesthesiaCOMBINATION_PRODUCT

The investigators used general anesthesia preoperatively in uniportal VATS lung surgery

general anesthesia group
epidural anesthesiaCOMBINATION_PRODUCT

The investigators used general anesthesia combined with epidural anesthesia preoperatively in uniportal VATS lung surgery

epidural group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, GeneralAnesthesia, Epidural

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and AnalgesiaAnesthesia, Conduction

Central Study Contacts

yi li, Ph.D

CONTACT

13816836628loulan_queen@163.com

xiangting li, B.S.

CONTACT

13671864990524646417@qq.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2017

First Posted

October 17, 2017

Study Start

September 19, 2017

Primary Completion

March 31, 2018

Study Completion

March 31, 2018

Last Updated

October 17, 2017

Record last verified: 2017-09

Locations

CN(1)