GenderNCT03281213
Acute Postthoracotomy Pain - Impact of Gender
An observational study of Gender and Postoperative Pain, run by Medical University of Graz at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gender, Postoperative Pain, Thoracotomy
- What is being tested?
- Thoracotomy
- How many people
- 346 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jul 2010to 1 Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- open lung surgery between July 2010 and December 2014
Who cannot join
- redo-thoracotomy
- chest wall or rib resection
- other approach than lateral thoracotomy
- additional incision at other site (e.g. laparotomy)
- chest trauma
- mesothelioma
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Graz, Division of Thoracic and Hyperbaric Surgery
Graz, Styria, 8036
About this study
Official title: No Impact of Gender on Acute Postthoracotomy Pain - a Retrospective Analysis
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.
- Conditions
- Gender, Postoperative Pain, Thoracotomy, Analgesia
- Being tested
- Thoracotomy
- Medical subject headings
- Coitus, Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThoracotomyOther
| Study group | Role | What they receive |
|---|---|---|
| Female | Not described Receives: Other: Thoracotomy | |
| Male | Not described Receives: Other: Thoracotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scores
Measured: first 5 postoperative days
Analgesics requirement
Measured: first 5 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start1 Jul 2010
- Primary completion31 Dec 2014
- Study completion1 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GenderStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 346 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Auinger, Daniel MD, Medical University of Graz
- Investigators
- Daniel Auinger, MD, Principal investigator, Medical University of GrazFreyja-Maria Smolle-Jüttner, Study director, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03281213
- Sponsor's protocol ID
- genderthorpain
- Status last verified
- Sep 2017
- First submitted
- 11 Sep 2017
- Last updated
- 13 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- No Impact of Gender on Acute Postthoracotomy Pain - a Retrospective Analysis
- ClinicalTrials.gov ID
- NCT03281213
- Acronym / sponsor ID
- genderthorpain
- Conditions
- Gender, Postoperative Pain, Thoracotomy, Analgesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 346 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 1 Jul 2010
- Primary completion
- 31 Dec 2014 (actual)
- Study completion
- 1 Jun 2016 (actual)
- First posted
- 13 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Female | – | Other: Thoracotomy |
| Male | – | Other: Thoracotomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- open lung surgery between July 2010 and December 2014
Key exclusion criteria (10 listed)
- redo-thoracotomy
- chest wall or rib resection
- other approach than lateral thoracotomy
- additional incision at other site (e.g. laparotomy)
- chest trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracotomy | Other | Female, Male |
Primary outcome
Visual Analogue Scores
Time frame: first 5 postoperative days
Analgesics requirement
Time frame: first 5 postoperative days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2017.
- Derived from this study: PubMed 31891695Auinger 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Auinger, MD principal investigator
Medical University of Graz
Freyja-Maria Smolle-Jüttner study director
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gender and Postoperative Pain, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scores (time frame: first 5 postoperative days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03281213, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2017.