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ROPI Study : Ropivacaine Interest in Postsurgical Pain After Mastectomy

Information source: Centre Jean Perrin
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain After Mastectomy

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

Phase: Phase 2

Status: Recruiting

Sponsored by: Centre Jean Perrin

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.

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Daily consumption of morphine during the first 48 postoperative hours.

Secondary outcome:

Determination of Ropivacaine plasma (analytical blank: T0)

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

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

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

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).

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.

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.

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.

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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

Locations and Contacts

Centre Jean Perrin, Clermont-Ferrand 63011, France; Recruiting
Emilie Monrigal, MD, Email: Emilie.MONRIGAL@cjp.fr
Catherine Abrial, PhD, Phone: (33) 4 73 87 84 91, Email: Catherine.ABRIAL@jp.fr
Emilie Monrigal, MD, Principal Investigator
Additional Information

Starting date: April 2013
Last updated: July 4, 2014

Page last updated: August 23, 2015

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