Pain, PostoperativeIncisionPainNCT02237963
Influence of the Surgical Approach on the Development of a Chronic Pain After Thoracic Surgery
An observational study of Pain, Postoperative, run by Hopital Foch at 1 site in France.
Trial summary
The prevalence of chronic pain after a thoracotomy is around 48 %. This research focuses on the surgical approach. The posterolateral approach is compared to the axillary approach especially in term of development of a chronic pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Posterolateral thoracotomy and Axillary thoracotomy
- Type of treatment
- Surgery or procedure
- How many people
- 209 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2014to Mar 2016
- How long will I take part?
- 4 Months
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing thoracic surgery by posterolateral or axillary thoracotomy, having no exclusion criteria for the study,
Who may be able to join
- patients undergoing thoracic surgery intervention by posterolateral or axillary thoracotomy, having no exclusion criteria for the study,
Who cannot join
- planned surgery by thoracoscopy or extended surgery,
- mental disability,
- vulnerable person within the meaning of French law,
- inability to communicate by phone,
- poor understanding of French.
Trial locations and contacts
1 site in 1 country.
About this study
The prevalence of chronic pain after a thoracotomy is around 48 %. This research focuses on the surgical approach. The posterolateral approach is compared to the axillary approach especially in term of development of a chronic pain.
- Conditions
- Pain, Postoperative
- Being tested
- Posterolateral thoracotomy, Axillary thoracotomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterolateral thoracotomyProcedure or surgery
Axillary thoracotomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Posterolateral thoracotomy | Surgeons perform a posterolateral thoracotomy Receives: Procedure: Posterolateral thoracotomy | |
| Axillary thoracotomy | Surgeons perform an axillary thoracotomy Receives: Procedure: Axillary thoracotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic pain
Prevalence of pain 4 months after surgery. Pain is evaluated using a numeric scale ranging from 0 (no pain) to 10 (maximal pain)
Measured: 4 months
Secondary outcomes (6)
Early postoperative pain
Evolution of pain from postoperative day 1 to postoperative day 6 ("pain trajectory") Prevalence of pain 5 to 7 days after surgery. Pain is evaluated using a numeric scale ranging from 0 (no pain) to 10 (maximal pain).
Clinical examination to detect modification of skin sensibility
Measured: 7 days
Characteristics of chronic pain
Characteristics are notably:
- its localization and intensity,
- its neuropathic origin,
- its impact on daily life,
- required analgesic treatment,
- need for a specific pain consultation
Measured: 4 months
Quality of life
Specific questionnaire
Measured: 4 months
Catastrophism
Score of Sullivan
Measured: 4 months
Anxiety
Stai trait
Measured: 4 months
Preventive role of epidural analgesia
Proportion of patients with chronic pain in each cohort who had had a postoperative thoracic epidural analgesia
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study startJul 2014
- Primary completionMar 2016
- Study completionMar 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 Pain, PostoperativeStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 209 participants (actual)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mireille Michel-Cherqui, MD, Principal investigator, Hôpital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02237963
- Sponsor's protocol ID
- 2013/50
- Other IDs
- 2013- A01641-44
- Acronym
- IncisionPain
- Status last verified
- Oct 2016
- First submitted
- 9 Sep 2014
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Ringsted TK, Wildgaard K, Kreiner S, Kehlet H. Pain-related impairment of daily activities after thoracic surgery: a questionnaire validation. Clin J Pain. 2013 Sep;29(9):791-9. doi: 10.1097/AJP.0b013e318278d4e2.
PubMed 23370071
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Surgical Approach on the Development of a Chronic Pain After Thoracic Surgery
- ClinicalTrials.gov ID
- NCT02237963
- Acronym / sponsor ID
- IncisionPain / 2013/50
- Conditions
- Pain, Postoperative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 12 Sep 2014 (estimated)
- 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.
The prevalence of chronic pain after a thoracotomy is around 48 %. This research focuses on the surgical approach. The posterolateral approach is compared to the axillary approach especially in term of development of a chronic pain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Posterolateral thoracotomy | – | Procedure: Posterolateral thoracotomySurgeons perform a posterolateral thoracotomy |
| Axillary thoracotomy | – | Procedure: Axillary thoracotomySurgeons perform an axillary thoracotomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing thoracic surgery by posterolateral or axillary thoracotomy, having no exclusion criteria for the study,
Key inclusion criteria (1 listed)
- patients undergoing thoracic surgery intervention by posterolateral or axillary thoracotomy, having no exclusion criteria for the study,
Key exclusion criteria (5 listed)
- planned surgery by thoracoscopy or extended surgery,
- mental disability,
- vulnerable person within the meaning of French law,
- inability to communicate by phone,
- poor understanding of French.
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 |
|---|---|---|
| Posterolateral thoracotomy | Procedure or surgery | Posterolateral thoracotomy |
| Axillary thoracotomy | Procedure or surgery | Axillary thoracotomy |
Primary outcome
Chronic pain
Time frame: 4 months
Prevalence of pain 4 months after surgery. Pain is evaluated using a numeric scale ranging from 0 (no pain) to 10 (maximal pain)
6 secondary outcomes
Early postoperative pain
Time frame: 7 days
Characteristics of chronic pain
Time frame: 4 months
Quality of life
Time frame: 4 months
Catastrophism
Time frame: 4 months
Anxiety
Time frame: 4 months
Preventive role of epidural analgesia
Time frame: 4 months
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 31 Oct 2016.
- Background: PubMed 23370071Ringsted TK, Wildgaard K, Kreiner S, Kehlet H. Pain-related impairment of daily activities after thoracic surgery: a questionnaire validation. Clin J Pain. 2013 Sep;29(9):791-9. doi: 10.1097/AJP.0b013e318278d4e2.
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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.
Mireille Michel-Cherqui, MD principal investigator
Hôpital Foch
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 Pain, Postoperative, run by Hopital Foch at 1 site in France.
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 5 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 31 Oct 2016. 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 France. 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?
Chronic pain (time frame: 4 months). 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 NCT02237963, 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 31 Oct 2016.