From Acute to Chronic Postoperative Pain in Patients for... | NCT01546480

Studies
From Acute to Chronic Postoperative Pain in Patients for Elective Cholecystectomy. Immunological Tests

NCT01546480

Sponsor

Odense University Hospital

Status

Completed

Last Update Posted

Jun 17, 2014Estimated

Enrollment

18Actual

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

ID	Type	Description	Link
119	Other Identifier	hhh

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

Nov 2011

Primary Completion Date

Feb 2014Actual

Completion Date

Feb 2014Actual

First Submitted Date

Mar 2, 2012

First Submission Date that Met QC Criteria

Mar 6, 2012

First Posted Date

Mar 7, 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
Oberstinde Kirsten Jensa la Cours Foundation	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

Chronic Pain after Cholecystectomy is a well known problem. One theory is that it is due to persisting inflammation.

The purpose of the study is to measure inflammatory factors in cerebrospinal fluid and blod at patients 12 months after the operation.

DNA-samples are collected to examine genetical factors, important for perception of pain, and the development of chronic pain.

Detailed Description

Not provided

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

Retention

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pain patients		Patients with unexplained chronic abdominal pain 12 months after elective cholecystectomy
Operated painfree Patients		Painfree patients 12 months after elective cholecystectomy
Nonoperated painfree patients		Painfree patients with no previous abdominal operation

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Spinal interleukine levels	12 months after surgery	12 months

Secondary Outcomes

Measure	Description	Time Frame
Blood interleukine levels		12 Months
spinal enzyme levels	12 months after surgery	12 months
Blood enzyme levels

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Group 1:

Inclusion Criteria:

Unexplained abdominal pain 12 months after elective cholecystectomy

Exclusion Criteria:

Immunosuppressive treatment (NSAID excepted)
Anticoagulant treatment

Group 2:

Inclusion Criteria:

No pain 12 months after elective cholecystectomy

Exclusion Criteria:

Immunosuppressive treatment (NSAID excepted)
Anticoagulant treatment

Group 3:

Inclusion Criteria:

Elective operation in spinal anesthesia or
Or healthy volunteers accepting samples of blod, cerebral spinal fluid and saliva, to be collected

Exclusion Criteria:

Acute or chronic pain condition
Immunosuppressive treatment (NSAID excepted)
Previous abdominal operation

Accepts Healthy Volunteers

Yes

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

Patients in group 1 and 2 previously participated in a study of postcholecystectomy pain.

Patients in group 3 are patients scheduled for elective surgery in spinal anesthesia at the participating centres.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Odense University Hospital		Odense		5000	Denmark
Lillebælt Hospital

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain
D010149	Pain, Postoperative
D007249	Inflammation

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D011183	Postoperative Complications

Browse Leaves

Not provided

Browse Branches

Not provided