NCT00129597

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4 pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 12, 2005

Completed
Last Updated

March 12, 2007

Status Verified

March 1, 2007

First QC Date

August 10, 2005

Last Update Submit

March 9, 2007

Conditions

PainBreast Cancer

Keywords

KetalarNMDAmastectomypostoperative chronic painChronic pain after mastectomy for breast cancer

Outcome Measures

Primary Outcomes (2)

  • 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 (1)

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

Interventions

ketalarDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mastectomy in patients 18 to 80 years old

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

MeSH Terms

Conditions

PainBreast NeoplasmsPain, Postoperative

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPostoperative ComplicationsPathologic Processes

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Vincent PIRIOU, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 10, 2005

First Posted

August 12, 2005

Study Start

December 1, 2004

Last Updated

March 12, 2007

Record last verified: 2007-03

Locations

FR(1)