NCT03281213

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
346

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2010

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2014

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 13, 2017

Completed
Last Updated

September 13, 2017

Status Verified

September 1, 2017

Enrollment Period

4.5 years

First QC Date

September 11, 2017

Last Update Submit

September 12, 2017

Conditions

Outcome Measures

Primary Outcomes (2)

  • Visual Analogue Scores

    first 5 postoperative days

  • Analgesics requirement

    first 5 postoperative days

Study Arms (2)

Female

Other: Thoracotomy

Male

Other: Thoracotomy

Interventions

FemaleMale

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample

You may qualify if:

  • open lung surgery between July 2010 and December 2014

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Graz, Division of Thoracic and Hyperbaric Surgery

Graz, Styria, 8036, Austria

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

CoitusPain, PostoperativeAgnosia

Interventions

Thoracotomy

Condition Hierarchy (Ancestors)

Sexual BehaviorBehaviorPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

Thoracic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Daniel Auinger, MD

    Medical University of Graz

    PRINCIPAL INVESTIGATOR
  • Freyja-Maria Smolle-Jüttner

    Medical University of Graz

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med. univ.

Study Record Dates

First Submitted

September 11, 2017

First Posted

September 13, 2017

Study Start

July 1, 2010

Primary Completion

December 31, 2014

Study Completion

June 1, 2016

Last Updated

September 13, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations