ROPI Study : Ropivacaine Interest in Postsurgical Pain After Mastectomy

Study Overview
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Brief Summary
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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.

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

Conditions
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Pain After Mastectomy

Intervention / Treatment
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* Drug: Ropivacaine in one arm and placebo (NaCl) in the other arm


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ropivacaine arm<br>Ropivacaïne 2 mg/ml 10ml/h | Drug: Ropivacaine in one arm and placebo (NaCl) in the other arm<br> <br> |
| Placebo Comparator: NaCl arm<br>NaCl 0,9% 250ml 10 ml/h | Drug: Ropivacaine in one arm and placebo (NaCl) in the other arm<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily consumption of morphine during the first 48 postoperative hours. |  | during the first 48 postoperative hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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: • 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: • 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: A potential analgesics administered |  | 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: 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 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: 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ropivacaine, pain, mastectomy