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
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