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CompletedNCT03281213Updated Sep 13, 2017

Acute Postthoracotomy Pain - Impact of Gender

An observational study in Gender, Postoperative Pain and Thoracotomy, sponsored by Medical University of Graz. Completed at 1 site in Austria. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-13.

Sponsored by Medical University of Graz · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
346
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Gender
  • Postoperative Pain
  • Thoracotomy
  • Analgesia

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Inclusion criteria

  • open lung surgery between July 2010 and December 2014

Exclusion criteria

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
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Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
346 participants (actual)
Patient registry
No

Groups and cohorts

  • Female

    Other: Thoracotomy

  • Male

    Other: Thoracotomy

Interventions

  • OtherThoracotomy
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What researchers measure

Primary outcomes

  1. Visual Analogue Scores

    Time frame: first 5 postoperative days

  2. Analgesics requirement

    Time frame: first 5 postoperative days

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Study locations

1 site
  • Medical University of Graz, Division of Thoracic and Hyperbaric Surgery
    Graz, Styria 8036, Austria
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References and documents

Publications

  • 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. PubMed 31891695 ↗

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT03281213
Lead sponsor
Medical University of Graz
Responsible party
Auinger, Daniel MD (Dr. med. univ., Medical University of Graz) — Principal investigator
First posted
Sep 13, 2017
Start date
Jul 1, 2010
Primary completion
Dec 31, 2014
Completion
Jun 1, 2016
Last update
Sep 13, 2017

Study contacts

Daniel Auinger, MD
principal investigator · Medical University of Graz
Freyja-Maria Smolle-Jüttner
study director · Medical University of Graz

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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