Trial Information
ROPI Study: Evaluation of the Interest of Ropivacaine Streaming in Postoperative Pain After Mastectomy.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Daily consumption of morphine during the first 48 postoperative hours.
Outcome Time Frame:
during the first 48 postoperative hours
Safety Issue:
No
Authority:
France: Committee for the Protection of Personnes
Study ID:
2012-000227-40
NCT ID:
NCT01855529
Start Date:
April 2013
Completion Date:
April 2015
Related Keywords:
- Pain After Mastectomy
- ropivacaine, pain, mastectomy