NCT03847363

Brief Summary

This study would compare acute and chronic postsurgical pain in patients underwent thoracic surgery with different anesthesia and analgesia methods, and explore the influencing factors.

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
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Typical duration for all trials

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

April 1, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 20, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
Last Updated

February 20, 2019

Status Verified

February 1, 2019

Enrollment Period

1.8 years

First QC Date

February 10, 2019

Last Update Submit

February 18, 2019

Conditions

Outcome Measures

Primary Outcomes (4)

  • numerical rating scale of acute postsurgical pain

    numerical rating scale is a 11-point scale for patient self-reporting of pain, in which 0 stands for no pain and 10 stands for the most severe pain.

    at day1 post-operation

  • numerical rating scale of acute postsurgical pain

    numerical rating scale is a 11-point scale for patient self-reporting of pain, in which 0 stands for no pain and 10 stands for the most severe pain.

    at day2 post-operation

  • numerical rating scale of chronic postsurgical pain

    numerical rating scale is a 11-point scale for patient self-reporting of pain, in which 0 stands for no pain and 10 stands for the most severe pain.

    at 3rd month post-operation

  • numerical rating scale of chronic postsurgical pain

    numerical rating scale is a 11-point scale for patient self-reporting of pain, in which 0 stands for no pain and 10 stands for the most severe pain.

    at 6th month post-operation

Study Arms (3)

general anesthesia

patients underwent general anesthesia

general and epidural anesthesia

patients underwent general and epidural anesthesia

Procedure: epidural anesthesia

general anesthesia combined with nerve block

patients underwent general anesthesia combined with nerve block

Procedure: nerve block

Interventions

epidural anesthesia

general and epidural anesthesia
nerve blockPROCEDURE

paravertebral or serratus anterior plane block

general anesthesia combined with nerve block

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

patients underwent selective thoracic surgery meeting inclusion and exclusion criteria

You may qualify if:

  • ASA I-II
  • underwent selective thoracic surgery

You may not qualify if:

  • with severe cardiac, endocrine,immunologic or haematologic diseases
  • medical history of chronic pain problems in chest area
  • medical history of pain-relief or sedative medication
  • not able to communicate with investigators

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Acute PainPain, Postoperative

Interventions

Anesthesia, EpiduralNerve Block

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaDenervationNeurosurgical ProceduresSurgical Procedures, Operative

Study Officials

  • jing cang

    Shanghai Zhongshan Hospital

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2019

First Posted

February 20, 2019

Study Start

April 1, 2018

Primary Completion

December 31, 2019

Study Completion

July 30, 2020

Last Updated

February 20, 2019

Record last verified: 2019-02

Locations