Chlorhydrate of Ropivacaine and Breast Cancer Surgery

Phase 4

Completed

• Conditions: Pain,Postoperative; Breast Neoplasms
• Interventions: Drug: Chlorhydrate de Ropivacaine; Other: placebo

• Registration Number: NCT00370240
• Lead Sponsor: Institut Curie

Brief Summary

The aim of the study is to evaluate the effect of local anesthetic (chlorhydrate of ropivacaine) to prevent chronic pain after breast surgery for cancer.

Detailed Description

An estimated 20-65% of women treated with breast surgery for breast cancer experience chronic pain in the treated breast. Patients will be randomize between: infiltration with chlorhydrate of ropivacaine at the time of breast surgery for cancer versus placebo.Intra-operative analgesia will be standardized as well as peri-operative pain management.

Study Timeline

• Study First Submitted: 2006-08-30
• Study First Submitted QC: 2006-08-30
• Study First Posted: 2006-08-31
• Study Start: 2006-09
• Status Verified: 2007-07
• Primary Completion: 2007-07
• Study Completion: 2008-11
• Last Update Submitted: 2017-11-02
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 260

Inclusion Criteria

• Breast cancer patients treated by conservative surgery with axillary node dissection or treated by mastectomy with or without axillary node dissection or sentinel lymph node biopsy.
• ASA physical status 1, 2 or 3
• With a minimum life expectancy of 2 years
• Written informed consent

Exclusion Criteria

• Any previous cancer other than breast cancer
• Allergies to local anesthesic and morphine
• Reported history of drug
• Pregnancy
• Homolateral breast surgery during the last 3 years
• Analgesic use pre-operatively
• Renal, pulmonary or liver major dysfunction
• Active malignant disease
• Unable to follow the protocol for any reason

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ropivacaïne	Chlorhydrate de Ropivacaine	-
placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
Comparing the frequencies of chronic breast pain 3 months after breast surgery evaluated by the Brief Pain Inventory in the two groups.	3 months after surgery

Secondary Outcome Measures

Name	Time	Method
Visual Analogic Scale, Patient satisfaction with analgesic, consumption, neuropathic pain and depression/anxiety rating scale	2 hours after surgery

Trial Locations

Locations (1)

René Huguenin Center; 🇫🇷 Saint-Cloud, France