Acute Postthoracotomy Pain - Impact of Gender | NCT03281213

Studies
Acute Postthoracotomy Pain - Impact of Gender

NCT03281213

Sponsor

Medical University of Graz

Status

Completed

Last Update Posted

Sep 13, 2017Actual

Enrollment

346Actual

Phase

Not provided

Conditions

Gender
Postoperative Pain
Thoracotomy
Analgesia

Interventions

Thoracotomy

Countries

Austria

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

Sep 2017

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

Jul 1, 2010

Primary Completion Date

Dec 31, 2014Actual

Completion Date

Jun 1, 2016Actual

First Submitted Date

Sep 11, 2017

First Submission Date that Met QC Criteria

Sep 12, 2017

First Posted Date

Sep 13, 2017Actual

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

Sep 12, 2017

Last Update Posted Date

Sep 13, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Adequate analgesia in thoracic surgery is essential to prevent severe postoperative complications, especially respiratory problems. Current knowledge about gender-related differences in pain states generally more frequent and intense pain and more demand for analgesics in women. Results about postsurgical pain in particular are very inconclusive.

The investigators tried to find out if gender has an influence on postthoracotomy pain and analgesics requirement.

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

346Actual

Label	Type	Description	Intervention Names
Female			Other: Thoracotomy
Male			Other: Thoracotomy

Name	Type	Description	Arm Group Labels	Other Names
Thoracotomy	Other		Female Male

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual Analogue Scores		first 5 postoperative days
Analgesics requirement		first 5 postoperative days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

open lung surgery between July 2010 and December 2014

Exclusion Criteria:

redo-thoracotomy
chest wall or rib resection
other approach than lateral thoracotomy
additional incision at other site (e.g. laparotomy)
chest trauma
mesothelioma
hemofiltration or haemodialysis
longer than one day stay at intensive care unit
pre-existent chronic pain and/or chronic opioid intake
short stay in hospital

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Daniel Auinger, MD	Medical University of Graz	Principal Investigator
Freyja-Maria Smolle-Jüttner	Medical University of Graz	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Graz, Division of Thoracic and Hyperbaric Surgery		Graz	Styria	8036	Austria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31891695	Derived	Auinger D, Sandner-Kiesling A, Striessnig A, Lindenmann J, Smolle J, Friedl H, Smolle-Juttner FM. Is There an Impact of Sex on Acute Postthoracotomy Pain? A Retrospective Analysis. Ann Thorac Surg. 2020 Apr;109(4):1104-1111. doi: 10.1016/j.athoracsur.2019.11.016. Epub 2019 Dec 28.

ID	Term
D003075	Coitus
D010149	Pain, Postoperative
D000377	Agnosia

ID	Term
D012725	Sexual Behavior
D001519	Behavior
D011183	Postoperative Complications
D010335	Pathologic Processes

ID	Term
D019616	Thoracic Surgical Procedures
D013514	Surgical Procedures, Operative