Effect of Ketalar to Prevent Postoperative Chronic Pain A... | NCT00129597

Studies
Effect of Ketalar to Prevent Postoperative Chronic Pain After Mastectomy

NCT00129597

Sponsor

Hospices Civils de Lyon

Status

Unknown status

Last Update Posted

Mar 12, 2007Estimated

Enrollment

Phase

Phase 4

Conditions

Pain
Breast Cancer

Interventions

ketalar

Countries

France

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

Mar 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2004

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Aug 10, 2005

First Submission Date that Met QC Criteria

Aug 10, 2005

First Posted Date

Aug 12, 2005Estimated

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

Mar 9, 2007

Last Update Posted Date

Mar 12, 2007Estimated

Description Module

Brief Summary

Prevalence of chronic pain after mastectomy is beyond 50% 3 months after surgery. This pain is related to a sensitization of the central nervous system through N-methyl-D-asparate (NMDA) receptors. Ketalar might prevent the occurrence of chronic pain by anti-NMDA properties after mastectomy.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
ketalar	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate the effect of perioperative ketalar on pain intensity 3 months after a mastectomy
Pain intensity is evaluated by an appropriate questionnaire 1 and 3 months after surgery.

Secondary Outcomes

Measure	Description	Time Frame
To evaluate the incidence of chronic pain after mastectomy, the impact on life quality, and the area of hyperalgesia

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Mastectomy in patients 18 to 80 years old

Exclusion Criteria:

American Society of Anesthesiology (ASA) class >= 3
Renal, heart or hepatic failure
Allergy to ketalar
Psychiatric disease
Chronic antalgic treatment

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vincent PIRIOU, MD	Hospices Civils de Lyon	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Lyon Sud		Pierre-Bénite		69495	France

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain
D001943	Breast Neoplasms
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007649	Ketamine

Ancestor Terms

ID	Term
D003510	Cyclohexanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic

Browse Leaves

Not provided

Browse Branches

Not provided