ROPI Study : Ropivacaine Interest in Postsurgical Pain After Mastectomy (ROPI)

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

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 Overview

• Status: Completed
• Conditions: Pain After Mastectomy
• Intervention / Treatment: Drug: Ropivacaine in one arm and placebo (NaCl) in the other arm

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63011
    • Centre Jean Perrin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Ropivacaine arm; Ropivacaïne 2 mg/ml 10ml/h	Drug: Ropivacaine in one arm and placebo (NaCl) in the other arm
PLACEBO_COMPARATOR: NaCl arm; NaCl 0,9% 250ml 10 ml/h	Drug: Ropivacaine in one arm and placebo (NaCl) in the other arm

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Centre Jean Perrin

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (ACTUAL): August 1, 2016
• Study Completion (ACTUAL): August 1, 2016

Study Registration Dates

• First Submitted: May 14, 2013
• First Submitted That Met QC Criteria: May 14, 2013
• First Posted (ESTIMATE): May 16, 2013

Study Record Updates

• Last Update Posted (ACTUAL): September 12, 2017
• Last Update Submitted That Met QC Criteria: September 11, 2017
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: ropivacaine, pain, mastectomy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 2012-000227-40