- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02149849
Surgical Positioning of the Arm During Thoracic Surgery -Effect on Shoulder Pain After Surgery?
January 29, 2024 updated by: Stein Ove Danielsen, Oslo University Hospital
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?
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Oslo, Norway
- Oslo University Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Men and women;18 years and older
- Thoracotomy for lung cancer
- Video assisted thoracic surgery for lung cancer.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Standard lateral positioning
|
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Experimental: Modified lateral positioning
Modified lateral positioning.
This will ensure less pressure and stretch on shoulder than standard 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative shoulder pain after lung surgery.
Time Frame: 3 months
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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 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain medication
Time Frame: 3 months
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All extra pain medication patient use after surgery until day 4, type and dose, will be mesaured.
|
3 months
|
White blood cell
Time Frame: 3 months
|
Mesaured before surgery, and at day 1 and 3 after surgery.
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3 months
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C reactive protein
Time Frame: 3 months
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Measured before surgery, and at day 1 and 3 after surgery.
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3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Stein O Danielsen, Oslo University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2014
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
May 20, 2014
First Submitted That Met QC Criteria
May 23, 2014
First Posted (Estimated)
May 29, 2014
Study Record Updates
Last Update Posted (Actual)
January 30, 2024
Last Update Submitted That Met QC Criteria
January 29, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014/406
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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