ROPI Study : Ropivacaine Interest in Postsurgical Pain After Mastectomy
Phase 2
Completed
- Conditions
- Pain After Mastectomy
- Interventions
- Registration Number
- NCT01855529
- Lead Sponsor
- Centre Jean Perrin
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 150
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NaCl arm Ropivacaine in one arm and placebo (NaCl) in the other arm NaCl 0,9% 250ml 10 ml/h Ropivacaine arm Ropivacaine in one arm and placebo (NaCl) in the other arm Ropivacaïne 2 mg/ml 10ml/h
- Primary Outcome Measures
Name Time Method Daily consumption of morphine during the first 48 postoperative hours. during the first 48 postoperative hours
- Secondary Outcome Measures
Name Time Method 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 During the first 48 h after surgery 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. during the 48h after the surgery 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 during the first 48h after the surgery 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 during 48h after the surgery 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 during the first 48h after the surgery Determination of Ropivacaine plasma (analytical blank: T0) T0, the day of surgery 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). during 48h after the surgery 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. during 48 hours after the surgery 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. during the 48h after the surgery
Trial Locations
- Locations (1)
Centre Jean Perrin
🇫🇷Clermont-Ferrand, France