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ROPI Study: Evaluation of the Interest of Ropivacaine Streaming in Postoperative Pain After Mastectomy.


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Pain After Mastectomy

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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

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