Chlorhydrate of Ropivacaine and Breast Cancer Surgery

Breast Neoplasms Clinical Trial

Official title:

Efficacy of Infiltration of Chlorhydrate of Ropivacaine in the Prevention of Chronic Breast Pain After Surgery for Breast Cancer.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00370240
• Other study ID #: (CRH 05353A)
• Secondary ID: EudraCT 2005-005
• Status: Completed
• Phase: Phase 4
• First received: August 30, 2006
• Last updated: November 2, 2017
• Start date: September 2006
• Est. completion date: November 2008

Study information

• Verified date: July 2007
• Source: Institut Curie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: November 2008
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Pain, Postoperative
• Pain,Postoperative

Intervention

Drug:
• Chlorhydrate de Ropivacaine
The Ropivacaïne group received 3mg/kg of 0.375% ropivacaïne(0.75% ropivacaïne, Astra, mixed with saline)

Other:
• placebo
The PCB group received saline solution in equal volume.

Locations

Country	Name	City	State
France	René Huguenin Center	Saint-Cloud

Sponsors (3)

Lead Sponsor	Collaborator
Institut Curie	AstraZeneca, Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Visual Analogic Scale, Patient satisfaction with analgesic, consumption, neuropathic pain and depression/anxiety rating scale		2 hours after surgery