Lung CancerNCT02149849
Surgical Positioning of the Arm During Thoracic Surgery -Effect on Shoulder Pain After Surgery?
A study testing Modified lateral positioning. in people with Lung Cancer, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Up to 85% experience shoulder pain after thoracic surgery, especially on the same side as surgery are performed. Referred phrenic nerve pain is probably one cause of ipsilateral shoulder pain (ISP), and positioning of the arm during surgery another. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Modified lateral positioning.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2014to Jan 2015
- 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
- Men and women;18 years and older
- Thoracotomy for lung cancer
- Video assisted thoracic surgery for lung cancer.
Who cannot join
- Received treatment for shoulder pain
- Use pain medication on regular basis
- Under 18 year
- Length of stay in ICU more than 24 hours after surgery
- Does not understand the native language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lateral Surgical Positioning for Thoracic Surgery -Effect on Ipsilateral Shoulder Pain?
Up to 85% experience shoulder pain after thoracic surgery, especially on the same side as surgery are performed. Referred phrenic nerve pain is probably one cause of ipsilateral shoulder pain (ISP), and positioning of the arm during surgery another. Studies indicates that ISP can be caused by the positioning of the patient during surgery due to muscle -and ligament strain. Can a change in the surgical positioning (less press and stretch) of the ipsilateral arm effect the shoulder pain after thoracic surgery?
- Conditions
- Lung Cancer
- Being tested
- Modified lateral positioning.
- Keywords
- Ipsilateral shoulder pain, Surgical positioning, Lung cancer, Thoracotomy, Video assisted thoracic surgery
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified lateral positioning.Procedure or surgery
Right before surgery, the patient are posistioned in lateral position with arm elevated (not more than 90 degree from torso). In the intervention, the arm will be lowered and placed in towards the torso for patients enrolled in the experimantal arm.
| Study group | Role | What they receive |
|---|---|---|
| Standard lateral positioning | No intervention | Not described |
| Modified lateral positioning | Experimental | Modified lateral positioning. This will ensure less pressure and stretch on shoulder than standard lateral positioning. Receives: Procedure: Modified lateral positioning. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative shoulder pain after lung surgery.
Using visual analog scale for assesing pain in the shoulder (Scale from 0-10). Mesauring times: VAS pain related to the shoulder before surgery, VAS pain shoulder at day 1 and 3 after surgery. Further will Oslo University Hospital scheme for registration of pain for location and characteristic also be used.
Measured: 3 months
Secondary outcomes (3)
Pain medication
All extra pain medication patient use after surgery until day 4, type and dose, will be mesaured.
Measured: 3 months
White blood cell
Mesaured before surgery, and at day 1 and 3 after surgery.
Measured: 3 months
C reactive protein
Measured before surgery, and at day 1 and 3 after surgery.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startAug 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stein Ove Danielsen, Oslo University Hospital
- Investigators
- Stein O Danielsen, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02149849
- Sponsor's protocol ID
- 2014/406
- Status last verified
- Jan 2024
- First submitted
- 20 May 2014
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lateral Surgical Positioning for Thoracic Surgery -Effect on Ipsilateral Shoulder Pain?
- ClinicalTrials.gov ID
- NCT02149849
- Acronym / sponsor ID
- 2014/406
- Conditions
- Lung Cancer
- Keywords
- Ipsilateral shoulder pain, Surgical positioning, Lung cancer, Thoracotomy, Video assisted thoracic surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 29 May 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.
Up to 85% experience shoulder pain after thoracic surgery, especially on the same side as surgery are performed. Referred phrenic nerve pain is probably one cause of ipsilateral shoulder pain (ISP), and positioning of the arm during surgery another. Studies indicates that ISP can be caused by the positioning of the patient during surgery due to muscle -and ligament strain. Can a change in the surgical positioning (less press and stretch) of the ipsilateral arm effect the shoulder pain after thoracic surgery?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard lateral positioning | No intervention | – |
| Modified lateral positioning | Experimental | Procedure: Modified lateral positioning.Modified lateral positioning. This will ensure less pressure and stretch on shoulder than standard lateral positioning. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women;18 years and older
- Thoracotomy for lung cancer
- Video assisted thoracic surgery for lung cancer.
Key exclusion criteria (5 listed)
- Received treatment for shoulder pain
- Use pain medication on regular basis
- Under 18 year
- Length of stay in ICU more than 24 hours after surgery
- Does not understand the native language
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 |
|---|---|---|
| Modified lateral positioning.Right before surgery, the patient are posistioned in lateral position with arm elevated (not more than 90 degree from torso). In the intervention, the arm will be lowered and placed in towards the torso for patients enrolled in the experimantal arm. | Procedure or surgery | Modified lateral positioning |
Primary outcome
Postoperative shoulder pain after lung surgery.
Time frame: 3 months
Using visual analog scale for assesing pain in the shoulder (Scale from 0-10). Mesauring times: VAS pain related to the shoulder before surgery, VAS pain shoulder at day 1 and 3 after surgery. Further will Oslo University Hospital scheme for registration of pain for location and characteristic also be used.
3 secondary outcomes
Pain medication
Time frame: 3 months
White blood cell
Time frame: 3 months
C reactive protein
Time frame: 3 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 30 Jan 2024.
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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.
Stein O Danielsen principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified lateral positioning. in people with Lung Cancer, run by Oslo University Hospital at 1 site in Norway.
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 3 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 30 Jan 2024. 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 Norway. 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?
Postoperative shoulder pain after lung surgery. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2024.