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
Information provided by:
Hospices Civils de Lyon
First received: August 10, 2005
Last updated: March 9, 2007
Last verified: March 2007
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.
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
||Effect of Ketalar to Prevent Postoperative Chronic Pain After Mastectomy
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:
| Study Start Date:
|Ages Eligible for Study:
||18 Years to 80 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Mastectomy in patients 18 to 80 years old
- American Society of Anesthesiology (ASA) class >= 3
- Renal, heart or hepatic failure
- Allergy to ketalar
- Psychiatric disease
- Chronic antalgic treatment
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00129597
|Centre Hospitalier Lyon Sud
|Pierre bénite, France, 69495 |
Hospices Civils de Lyon
||Vincent PIRIOU, MD
||Hospices Civils de Lyon
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 10, 2005
||March 9, 2007
||France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Keywords provided by Hospices Civils de Lyon:
postoperative chronic pain
Chronic pain after mastectomy for breast cancer
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 03, 2015
Nervous System Diseases
Signs and Symptoms