Postoperative Pain in Orbital Disease and Ocular Tumor | NCT02704715

Studies
Postoperative Pain in Orbital Disease and Ocular Tumor

NCT02704715

Sponsor

Sun Yat-sen University

Status

Unknown status

Last Update Posted

Mar 10, 2016Estimated

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Postoperative Pain

Interventions

general anesthesia,orbital operation

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2016

Primary Completion Date

Dec 2017Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Feb 25, 2016

First Submission Date that Met QC Criteria

Mar 9, 2016

First Posted Date

Mar 10, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2016

Last Update Posted Date

Mar 10, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the postoperative pain after general anesthesia of orbital diseases and ocular tumor patients.

Detailed Description

The purpose of this study is to evaluate patients diagnosed of orbital diseases or ocular tumor over 16 years old of the postoperative pain after general anesthesia , and to analyze the related factors of pain after operation.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
general anesthesia,orbital operation	Other	diagnosed as orbital disease and ocular tumor over 16 years old orbital operation under general anesthesia	Procedure: general anesthesia,orbital operation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
general anesthesia,orbital operation	Procedure	to evaluate the pain under general anesthesia	general anesthesia,orbital operation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pain	numerical rating scale, NRS will be used to measure the pain	24 hours after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

over 16 years old
diagnosed as orbital disease or ocular tumor
surgery under general anesthesia

Exclusion Criteria:

any uncontrolled clinical problems

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Huijing Ye, Master	Contact	+00862087331539		yehuijing@qq.com
Huasheng Yang, Doctor	Contact	+00862087331539		yanghs64@126.com

Overall Officials

Name	Affiliation	Role
Huijing Ye, Master	Sun Yat-sen University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sun Yat-sen University	Recruiting	Guangzhou	Guangdong	510000	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Mar 9, 2017
Reset	Apr 19, 2017
Release	Jun 15, 2017
Unrelease		Yes
Release	Jan 23, 2018
Reset	Nov 2, 2018

Submission Tracking

Estimated Results First Submitted Date

Mar 9, 2017

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Mar 9, 2017			Apr 19, 2017
Jun 15, 2017

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000768	Anesthesia, General

Ancestor Terms

ID	Term
D000758	Anesthesia
D000760	Anesthesia and Analgesia

Browse Leaves

Not provided

Browse Branches

Not provided