Clinical trial NCT01855529: ROPI Study : Ropivacaine Interest in Postsurgical Pain After Mastectomy
Official title: ROPI Study: Evaluation of the Interest of Ropivacaine Streaming in Postoperative Pain After Mastectomy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain After Mastectomy
Keywords: ropivacaine, pain, mastectomy
Lead sponsor: Centre Jean Perrin
Sponsor class: OTHER
First posted: 2013-05-16
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility 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

Primary outcomes:
measure: Daily consumption of morphine during the first 48 postoperative hours.
timeFrame: during the first 48 postoperative hours
Secondary outcomes:
measure: Determination of Ropivacaine plasma (analytical blank: T0)
timeFrame: T0, the day of surgery
measure: Assessment every 4 hours by the IDE that will support the patient during the first 48 hours, then every analgesic taken: • The intensity of pain, VAS or EN
timeFrame: During the first 48 h after surgery
measure: Assessment every 4 hours by the IDE that will support the patient during the first 48 hours, then every analgesic taken: • The site of pain
timeFrame: during the first 48h after the surgery
measure: Assessment every 4 hours by the IDE that will support the patient during the first 48 hours, then every analgesic taken: A potential analgesics administered
timeFrame: during the first 48h after the surgery
measure: Assessment every 4 hours by the IDE that will support the patient during the first 48 hours, then every analgesic taken: Constant: pulse, blood pressure, tympanic temperature, respiratory rate, sedation (0: awake, 1: sleepy, 2 comatose).
timeFrame: during 48h after the surgery
measure: Assessment every 4 hours by the IDE that will support the patient during the first 48 hours, then every analgesic taken: Possible side effects The most common expected morphine: nausea, vomiting, pruritus, acute urine retention.
timeFrame: during the 48h after the surgery
measure: Assessment every 4 hours by the IDE that will support the patient during the first 48 hours, then every analgesic taken: Possible side effects of ropivacaine expected the most common: nausea, vomiting, headache, dizziness, paresthesias.
timeFrame: during 48 hours after the surgery
measure: Assessment every 4 hours by the IDE that will support the patient during the first 48 hours, then every analgesic taken: Condition of dressing • On any abnormality at the site of administration: local redness, pain, skin warmth, pruritus.
timeFrame: during the 48h after the surgery
measure: Assessment every 4 hours by the IDE that will support the patient during the first 48 hours, then every analgesic taken: Determination of Ropivacaine plasma at T0+ 24 h, T0+48h
timeFrame: during 48h after the surgery
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
Study officials:
References: