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
  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:


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:
Breast Neoplasms
Chronic Pain
Breast Diseases
Neoplasms
Neoplasms by Site
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Skin Diseases
Ketamine
Analgesics
Anesthetics
Anesthetics, Dissociative
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014