ROPI Study : Ropivacaine Interest in Postsurgical Pain After Mastectomy

Centre Jean Perrin150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

150

Conditions

Pain After Mastectomy

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Daily consumption of morphine during the first 48 postoperative hours.

Time frame: during the first 48 postoperative hours

Secondary Outcomes

Determination of Ropivacaine plasma (analytical blank: T0)

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 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.