From ACute To Chronic Postoperative Shoulder Pain in Pati... | NCT01552746

Studies
From ACute To Chronic Postoperative Shoulder Pain in Patients for Elective Lobectomy

NCT01552746

Sponsor

Odense University Hospital

Status

Completed

Last Update Posted

Jun 17, 2014Estimated

Enrollment

60Actual

Phase

Not provided

Conditions

Pain

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Mar 2, 2012

First Submission Date that Met QC Criteria

Mar 9, 2012

First Posted Date

Mar 13, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 16, 2014

Last Update Posted Date

Jun 17, 2014Estimated

Name	Class
Vejle Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Shoulder pain is a well known problem after thoracical surgery. The pathogenesis of the pain is uncertain, but mainly a mix of referred pain and mechanical strain to the shoulder. It is believed to last a few days. Persisting shoulder pain after thoracical surgery is a problem 1 year after surgery, but it is unknown if it is related to acute postoperative shoulder pain.

The purpose of the study is to systematically describe postoperative shoulder pain after lobectomy and examine the time progress up to 1 year after surgery.

Detailed Description

Further study details are provided by Departement V, Odense University Hospital

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Shoulder Pain		12 months
Shoulder range of motion	Shoulder range of motion in: flexion, outward rotation, inward rotation, adduction	12 months

Secondary Outcomes

Measure	Description	Time Frame
Thoracical Pain		12 months
Presence of allodynia and hyperalgesia on the shoulder on the operated side.	Presence of allodynia and hyperalgesia on the shoulder on the operated side, compared to the contralateral shoulder.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients for elective lobectomy
18 years or older at the day of the operation
Satisfactory abilities to speak and read danish

Exclusion Criteria:

Previous Thoracical Surgery.
Patients with diseases in the nervous system.
Patients with preoperative shoulder pain, neuropathies or sensory disturbances in the arm or shoulder.
Patients who are reoperated in the thorax in the study period or any other body-region within the first 4 postoperative days.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Consecutive patients, scheduled for elective lobectomy of the lung at Odense University Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Morten R Eckhardt, MD	Departement V of anesthesia and intensive care, Odense University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Departement V of anesthesia and intensive care, Odense University Hospital		Odense		5000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided