ROPI Study : Ropivacaine Interest in Postsurgical Pain After Mastectomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Centre Jean Perrin
Sponsor:
Information provided by (Responsible Party):
Centre Jean Perrin
ClinicalTrials.gov Identifier:
NCT01855529
First received: May 14, 2013
Last updated: July 4, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Pain After Mastectomy
Drug: Ropivacaine in one arm and placebo (NaCl) in the other arm
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: ROPI Study: Evaluation of the Interest of Ropivacaine Streaming in Postoperative Pain After Mastectomy.

Resource links provided by NLM:


Further study details as provided by Centre Jean Perrin:

Primary Outcome Measures:
  • Daily consumption of morphine during the first 48 postoperative hours. [ Time Frame: during the first 48 postoperative hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determination of Ropivacaine plasma (analytical blank: T0) [ Time Frame: T0, the day of surgery ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: during the 48h after the surgery ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: during 48h after the surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: April 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01855529

Locations
France
Centre Jean Perrin Recruiting
Clermont-Ferrand, France, 63011
Contact: Emilie Monrigal, MD       Emilie.MONRIGAL@cjp.fr   
Contact: Catherine Abrial, PhD    (33) 4 73 87 84 91    Catherine.ABRIAL@jp.fr   
Principal Investigator: Emilie Monrigal, MD         
Sponsors and Collaborators
Centre Jean Perrin
  More Information

No publications provided

Responsible Party: Centre Jean Perrin
ClinicalTrials.gov Identifier: NCT01855529     History of Changes
Other Study ID Numbers: 2012-000227-40
Study First Received: May 14, 2013
Last Updated: July 4, 2014
Health Authority: France: Committee for the Protection of Personnes
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Jean Perrin:
ropivacaine, pain, mastectomy

Additional relevant MeSH terms:
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014