Skip to main content
OpenTrials
Completed

NCT Number: NCT01855529

ROPI Study : Ropivacaine Interest in Postsurgical 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain After Mastectomy Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine in one arm and placebo (NaCl) in the other arm

Drug

Primary outcomes

  1. Daily consumption of morphine during the first 48 postoperative hours.

    Time frame: during the first 48 postoperative hours

Secondary outcomes

  1. Determination of Ropivacaine plasma (analytical blank: T0)

    Time frame: T0, the day of surgery

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

Sponsors and collaborators

Lead sponsor

Centre Jean Perrin

Other

Registry information

Official study title

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

Acronym: ROPI

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
May 16, 2013
Registry last updated
Sep 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.