ROPI Study : Ropivacaine Interest in Postsurgical Pain After Mastectomy

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

After surgery for breast cancer, the prevalence of chronic pain is estimated between 20 and 68%. They begin after surgery and may persist until more than 6 months. They respond poorly to opioid analgesics impair the quality of life.

Among the different postoperative analgesic techniques used, the use of a local anesthetic infiltration continues catheter has advantages including improving the quality of analgesia, with a significant decrease in average of VAS (scale visual Analogue), a decrease in morphine consumption, improving the quality of life of patients.

Our study aims to evaluate the effectiveness of a continuous local anesthetic infiltration in the control of postoperative pain after mastectomy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Jean Perrin
• Treatments: Ropivacaine

Criteria

Inclusion Criteria:

Age> 18 years

• ASA I-II, WHO 0-1

• mastectomy alone, mastectomy + GGS + mastectomy CA

• No previous history of chronic pain requiring regular intake of analgesics or long-term

• Failure to take opioids within 30 days before surgery

Exclusion Criteria:

• Long-term treatment analgesic or taking opioids within 30 days before surgery

• Concurrent treatment with a drug test, participation in another therapeutic clinical trial within <30 days

• proven allergy to local anesthetics of the amide

• Skin Inflammation

• Sepsis local

• Kidney failure, liver failure, severe or poorly controlled diabetes

• Inability to respond to the assessment of pain using a visual analogue scale (VAS) or a numerical scale (FR).

• mastectomy with immediate breast reconstruction