Effect of Ketalar to Prevent Postoperative Chronic Pain After Mastectomy

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00129597

Enrollment

Registered

2005-08-12

Start date

2004-12-31

Completion date

Unknown

Last updated

2007-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Pain

Keywords

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

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.

Interventions

DRUGketalar

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	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

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026