Post-thoracotomy Pain SyndromePOVANCT04415242
IMPACT OF OPERATIVE POSITIONING ON THE DEVELOPMENT OF SHOULDER PAIN AFTER PULMONARY LOBECTOMY BY VATS
A study testing positioning in people with Post-thoracotomy Pain Syndrome, run by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec at 1 site in Canada.
Trial summary
The investigators want to be able to show a 66% decrease in the incidence of shoulder pain in the "support" group compared to the "suspension" group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-thoracotomy Pain Syndrome
- What is being tested?
- positioning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteCanada
- Study dates
- 18 Jun 2020to 30 Mar 2021
- Phase
- Interventional
- 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
Who may be able to join
- Any patient in whom the management of a bronchopulmonary cancer, or his strong suspicion, justifies a bilobectomy, a lobectomy or a segmentectomy by videothoracoscopy.
Who cannot join
- surgery extended to the chest wall, including extra-pleural resections,
- Pleurectomy,
- Chronic pain patient suffering from chronic pain preoperatively,
- Fibromyalgia patient,
- Chronic taking of analgesic or anti-inflammatory medications during the preoperative period, namely taking at least daily for more than 4 weeks,
- Patient with a history of orthopedic surgery of the upper limb ipsilateral to the surgery,
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- Patient with mechanical limitation of the joint range of the upper limb ipsilateral to surgery,
- Non-French speaking patient,
- Pregnant woman,
- Patient under 18-year-old,
- Patient whose BMI is greater than or equal to 35 kg / m2
- Glomerular filtration rate less than <50 ml / min
Trial locations and contacts
1 site in 1 country.
Anne Sophie Laliberté, MD contact
Canada1 site, 1 recruiting
- Recruiting
Institut Universitaire de Cardiologie et de pneumologie de Québec
Québec, Quebec, G1v4G5
Geraud Galvaing, MD, MSc, +14156564945, geraud.galvaing@clermont.unicancer.fr
Anne Sophie Laliberté, MD, +14186564945
About this study
The investigators want to be able to show a 66% decrease in the incidence of shoulder pain in the "support" group compared to the "suspension" group.
Read the detailed description
The position currently used in cases of pulmonary lobectomies by videothoracoscopy is an extension associated with an abduction of the shoulder on the side operated by suspension of the thoracic limb in a trampoline-type arm support with an angulation of more than 90 ° of the shoulder in the saggital and frontal planes.
The investigators wish to prospectively and randomly compare this position currently used in the thoracic surgery service of the IUCPQ with a 2nd position which seems less restrictive for all the joints of the shoulder joint complex in which the patient's arm rests on a support placed in front of the patient's face. It follows from this position of the joint degrees less than or equal to 90 ° in all planes. This new position is not experimental, but not normally used in thoracic surgery at the IUCPQ.
- Conditions
- Post-thoracotomy Pain Syndrome
- Being tested
- positioning
- Keywords
- VATS, shoulder pain, pulmonary resection
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
positioningOther
different positioning prior surgery
| Study group | Role | What they receive |
|---|---|---|
| suspension group | Active comparator | Arm on the side operated at 90 ° abduction, 90 ° anti-drive, resting on an arm support. Receives: Other: positioning |
| supported group | Experimental | Arm on the operated side at 0 ° abduction, 90 ° anti-pulsation, resting on an adjustable support arm support located opposite the patient's head. Receives: Other: positioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
post thoracoscopy shoulder pain measured on the Visual Pain Scale
postoperative shoulder pain measured on the Visual Pain Scale, its precise location on the patient's body will also be assessed
Measured: from the recovery unit to post-operative day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start18 Jun 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion30 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post-thoracotomy Pain SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geraud Galvaing, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04415242
- Sponsor's protocol ID
- 2020-3430, 21919
- Acronym
- POVA
- Status last verified
- Jul 2020
- First submitted
- 27 May 2020
- Last updated
- 15 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ip HY, Abrishami A, Peng PW, Wong J, Chung F. Predictors of postoperative pain and analgesic consumption: a qualitative systematic review. Anesthesiology. 2009 Sep;111(3):657-77. doi: 10.1097/ALN.0b013e3181aae87a.
PubMed 19672167Barak M, Ziser A, Katz Y. Thoracic epidural local anesthetics are ineffective in alleviating post-thoracotomy ipsilateral shoulder pain. J Cardiothorac Vasc Anesth. 2004 Aug;18(4):458-60. doi: 10.1053/j.jvca.2004.05.025.
PubMed 15365928
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPACT OF OPERATIVE POSITIONING ON THE DEVELOPMENT OF SHOULDER PAIN AFTER PULMONARY LOBECTOMY BY VATS
- ClinicalTrials.gov ID
- NCT04415242
- Acronym / sponsor ID
- POVA / 2020-3430, 21919
- Conditions
- Post-thoracotomy Pain Syndrome
- Keywords
- VATS, shoulder pain, pulmonary resection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de QuebecUniversity, hospital or other
- Study start
- 18 Jun 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 30 Mar 2021 (estimated)
- First posted
- 4 Jun 2020 (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.
The investigators want to be able to show a 66% decrease in the incidence of shoulder pain in the "support" group compared to the "suspension" group.
Detailed description
The position currently used in cases of pulmonary lobectomies by videothoracoscopy is an extension associated with an abduction of the shoulder on the side operated by suspension of the thoracic limb in a trampoline-type arm support with an angulation of more than 90 ° of the shoulder in the saggital and frontal planes.
The investigators wish to prospectively and randomly compare this position currently used in the thoracic surgery service of the IUCPQ with a 2nd position which seems less restrictive for all the joints of the shoulder joint complex in which the patient's arm rests on a support placed in front of the patient's face. It follows from this position of the joint degrees less than or equal to 90 ° in all planes. This new position is not experimental, but not normally used in thoracic surgery at the IUCPQ.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| suspension group | Active comparator | Other: positioningArm on the side operated at 90 ° abduction, 90 ° anti-drive, resting on an arm support. |
| supported group | Experimental | Other: positioningArm on the operated side at 0 ° abduction, 90 ° anti-pulsation, resting on an adjustable support arm support located opposite the patient's head. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient in whom the management of a bronchopulmonary cancer, or his strong suspicion, justifies a bilobectomy, a lobectomy or a segmentectomy by videothoracoscopy.
Key exclusion criteria (12 listed)
- surgery extended to the chest wall, including extra-pleural resections,
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 |
|---|---|---|
| positioningdifferent positioning prior surgery | Other | supported group, suspension group |
Primary outcome
post thoracoscopy shoulder pain measured on the Visual Pain Scale
Time frame: from the recovery unit to post-operative day 2
postoperative shoulder pain measured on the Visual Pain Scale, its precise location on the patient's body will also be assessed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
- Background: PubMed 19672167Ip HY, Abrishami A, Peng PW, Wong J, Chung F. Predictors of postoperative pain and analgesic consumption: a qualitative systematic review. Anesthesiology. 2009 Sep;111(3):657-77. doi: 10.1097/ALN.0b013e3181aae87a.
- Background: PubMed 15365928Barak M, Ziser A, Katz Y. Thoracic epidural local anesthetics are ineffective in alleviating post-thoracotomy ipsilateral shoulder pain. J Cardiothorac Vasc Anesth. 2004 Aug;18(4):458-60. doi: 10.1053/j.jvca.2004.05.025.
- Individual participant dataSharing planned: No
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.
Anne Sophie Laliberté, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing positioning in people with Post-thoracotomy Pain Syndrome, run by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec at 1 site in Canada.
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 12 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: status not confirmed, as of the sponsor's last update on 15 Jul 2020. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Geraud Galvaing, MD, MSc (+14186564945, geraud.galvaing@clermont.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post thoracoscopy shoulder pain measured on the Visual Pain Scale (time frame: from the recovery unit to post-operative day 2). 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 NCT04415242, which also lists 2 linked publications.
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 15 Jul 2020.