Effect of Ketalar to Prevent Postoperative Chronic Pain After Mastectomy

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2007 by Hospices Civils de Lyon.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Hospices Civils de Lyon

ClinicalTrials.gov Identifier:

NCT00129597

First received: August 10, 2005

Last updated: March 9, 2007

Last verified: March 2007

History of Changes

Purpose

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.

Condition	Intervention	Phase
Pain Breast Cancer	Drug: ketalar	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Effect of Ketalar to Prevent Postoperative Chronic Pain After Mastectomy

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Chronic Pain Mastectomy

Drug Information available for: Ketamine hydrochloride Ketamine

U.S. FDA Resources

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:

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 Outcome Measures:

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


Estimated Enrollment:	40
Study Start Date:	December 2004

Eligibility


Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00129597

Locations


France
Centre Hospitalier Lyon Sud
Pierre bénite, France, 69495

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators


Principal Investigator:	Vincent PIRIOU, MD	Hospices Civils de Lyon

More Information

No publications provided


ClinicalTrials.gov Identifier:	NCT00129597 History of Changes
Other Study ID Numbers:	2004.349
Study First Received:	August 10, 2005
Last Updated:	March 9, 2007
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:


Ketalar NMDA mastectomy postoperative chronic pain Chronic pain after mastectomy for breast cancer

Additional relevant MeSH terms:


Chronic Pain Nervous System Diseases Neurologic Manifestations Pain Signs and Symptoms

ClinicalTrials.gov processed this record on March 03, 2015

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