ROPI Study : Ropivacaine Interest in Postsurgical Pain After Mastectomy

Centre Jean Perrin

Status and phase: Completed; Phase 2

Conditions: Pain After Mastectomy

Treatments: Drug: Ropivacaine in one arm and placebo (NaCl) in the other arm

Study type: Interventional

Funder types: Other

Identifiers

NCT01855529

2012-000227-40

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups, including a placebo group

Ropivacaine arm

Experimental group

Description:

Ropivacaïne 2 mg/ml 10ml/h

Treatment:

Drug: Ropivacaine in one arm and placebo (NaCl) in the other arm

NaCl arm

Placebo Comparator group

Description:

NaCl 0,9% 250ml 10 ml/h

Treatment:

Drug: Ropivacaine in one arm and placebo (NaCl) in the other arm