Back to resultsSurgical Positioning of the Arm During Thoracic Surgery -Effect on Shoulder Pain After Surgery?
Primary Purpose
Lung Cancer
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Modified lateral positioning.
Sponsored by
About this trial
This is an interventional prevention trial for Lung Cancer focused on measuring Ipsilateral shoulder pain, Surgical positioning, Lung cancer, Thoracotomy, Video assisted thoracic surgery
Eligibility Criteria
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
Sites / Locations
- Oslo University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard lateral positioning
Modified lateral positioning
Arm Description
Modified lateral positioning. This will ensure less pressure and stretch on shoulder than standard lateral positioning.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Pain medication
All extra pain medication patient use after surgery until day 4, type and dose, will be mesaured.
White blood cell
Mesaured before surgery, and at day 1 and 3 after surgery.
C reactive protein
Measured before surgery, and at day 1 and 3 after surgery.
Full Information
NCT ID
NCT02149849
First Posted
May 20, 2014
Last Updated
January 14, 2015
Sponsor
Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02149849
Brief Title
Surgical Positioning of the Arm During Thoracic Surgery -Effect on Shoulder Pain After Surgery?
Official Title
Lateral Surgical Positioning for Thoracic Surgery -Effect on Ipsilateral Shoulder Pain?
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Ipsilateral shoulder pain, Surgical positioning, Lung cancer, Thoracotomy, Video assisted thoracic surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard lateral positioning
Arm Type
No Intervention
Arm Title
Modified lateral positioning
Arm Type
Experimental
Arm Description
Modified lateral positioning. This will ensure less pressure and stretch on shoulder than standard lateral positioning.
Intervention Type
Procedure
Intervention Name(s)
Modified lateral positioning.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postoperative shoulder pain after lung surgery.
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Pain medication
Description
All extra pain medication patient use after surgery until day 4, type and dose, will be mesaured.
Time Frame
3 months
Title
White blood cell
Description
Mesaured before surgery, and at day 1 and 3 after surgery.
Time Frame
3 months
Title
C reactive protein
Description
Measured before surgery, and at day 1 and 3 after surgery.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stein O Danielsen
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Surgical Positioning of the Arm During Thoracic Surgery -Effect on Shoulder Pain After Surgery?
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