Pain Prevalence After Cesarean Section in Siriraj Hospital | NCT02810639

Studies
Pain Prevalence After Cesarean Section in Siriraj Hospital

NCT02810639

Sponsor

Mahidol University

Status

Completed

Last Update Posted

Jun 23, 2016Estimated

Enrollment

297Actual

Phase

Not provided

Conditions

Pain, Postoperative

Interventions

Not provided

Countries

Thailand

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Jun 2013Actual

Completion Date

Jun 2013Actual

First Submitted Date

Jun 17, 2016

First Submission Date that Met QC Criteria

Jun 22, 2016

First Posted Date

Jun 23, 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

Jun 22, 2016

Last Update Posted Date

Jun 23, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

Spinal morphine has been widely provided for acute postoperative analgesia. However, the analgesic effect of spinal morphine usually last 12-24 hours. Therefore the investigators are interested in the pain characteristics during the 2nd postoperative day. The investigators will also explore the regimens for pain therapy in our hospital.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

297Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients who have moderate to severe pain after Cesarean section	Number of patients who have moderate to severe pain after Cesarean section	24-48 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing Cesarean section

Exclusion Criteria:

History of drug addict

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing Cesarean section

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sirilak Suksompong, MD	Mahidol University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sirilak Suksompong		Bangkok		10700	Thailand

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative
D010146	Pain

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009461	Neurologic Manifestations

Browse Leaves

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Browse Branches

Not provided