Status:
COMPLETED
ROPI Study : Ropivacaine Interest in Postsurgical Pain After Mastectomy
Lead Sponsor:
Centre Jean Perrin
Conditions:
Pain After Mastectomy
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 analge...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01855529
Start Date
April 1 2013
End Date
August 1 2016
Last Update
September 12 2017
Active Locations (1)
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1
Centre Jean Perrin
Clermont-Ferrand, France, 63011