From ACute To Chronic Postoperative Pain in Patients for... | NCT01553253

Studies
From ACute To Chronic Postoperative Pain in Patients for Elective Cholecystectomy

NCT01553253

Sponsor

Odense University Hospital

Status

Completed

Last Update Posted

Jun 17, 2014Estimated

Enrollment

100Actual

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

Apr 2010

Primary Completion Date

Jun 2012Actual

Completion Date

Jun 2012Actual

First Submitted Date

Mar 2, 2012

First Submission Date that Met QC Criteria

Mar 9, 2012

First Posted Date

Mar 14, 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

Sponsor/Collaborators Module

Responsible Party, by Official Title

Morten Rune Eckhardt, Afdelingslæge, Ph.D.-student, Odense University HospitalPrincipal Investigator

Lead Sponsor

Odense University HospitalOTHER

Collaborators

Name	Class
University of Southern Denmark	OTHER
Region of Southern Denmark	OTHER
Vejle Hospital	OTHER
Manufacturer Mads Clausen Foundation

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 is a wellknown complication after cholecystectomy. Intensity of the pain in the first week after the operation is a predictive factor for the development of chronic pain, but it is unknown whether the risk is more related to one of the different components of acute pain (ie somatic, visceral, referred). Furthermore the chronic pain has not been systematically described in terms of type of pain or sensory abnormalities etc. (allodynia, hyperalgesia etc.).

The purpose of the study is to examine whether intensity of components of acute pain is predictive for development of chronic pain after cholecystectomy and to characterize the chronic pain by quantitative sensory testing.

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

100Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Abdominal pain		12 months

Secondary Outcomes

Measure	Description	Time Frame
Quantitative sensory testing values in referred pain area.	Quantitative sensory testing values in referred pain area compared to contralateral side and preoperative values. The following quantitative sensory tests are performed: Cold Detection Threshold,Warm Detection Threshold, Cold Pain Threshold, Heat Pain Threshold, Mechanical detection Threshold, Mechanical Pain Threshold, Allodynia, Hyperalgesia, Wind-Up Ratio, Vibration Detection Threshold, Pressure Pain Threshold

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients for elective cholecystectomy
18 years or older at the day of the operation
Capable of speaking, reading and writing danish

Exclusion Criteria:

Previous abdominal operation
Patients with preoperative neuropathies
Patients with other diseases in the nervous system, preoperative paresthesias or other sensory disturbances.

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 for elective cholecystectomy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Odense University Hospital		Nyborg		5800	Denmark
Lillebælt Hospital

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain
D010149	Pain, Postoperative
D059265	Visceral Pain
D053591	Pain, Referred
D059226	Nociceptive Pain

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