NCT02149849

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable lung-cancer

Timeline
Completed

Started Aug 2014

Shorter than P25 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 29, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

5 months

First QC Date

May 20, 2014

Last Update Submit

January 29, 2024

Conditions

Lung Cancer

Keywords

Ipsilateral shoulder painSurgical positioningLung cancerThoracotomyVideo assisted thoracic surgery

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Secondary Outcomes (3)

  • Pain medication

    3 months

  • White blood cell

    3 months

  • C reactive protein

    3 months

Study Arms (2)

Standard lateral positioning

NO INTERVENTION

Modified lateral positioning

EXPERIMENTAL

Modified lateral positioning. This will ensure less pressure and stretch on shoulder than standard lateral positioning.

Procedure: Modified lateral positioning.

Interventions

Modified lateral positioning.PROCEDURE

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.

Modified lateral positioning

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women;18 years and older
  • Thoracotomy for lung cancer
  • Video assisted thoracic surgery for lung cancer.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, Norway

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Stein O Danielsen

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RN, MNSc

Study Record Dates

First Submitted

May 20, 2014

First Posted

May 29, 2014

Study Start

August 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

January 30, 2024

Record last verified: 2024-01

Locations

NO(1)