deltatrials
Terminated INTERVENTIONAL NCT02525211

Continues Cicatricial Perfusion of Ropivacaine Versus Placebo After Mastectomy : Rehabilitation After Treatment

Double-blind Randomized Prospective Phase III Study of a Continues Cicatricial Perfusion of Ropivacaine Versus Placebo After Mastectomy : Rehabilitation After Treatment of the Postoperative Pain From Hospital to Home

Sponsor: Institut Paoli-Calmettes

Conditions Breast Cancer
Updated 8 times since 2017 Last updated: Apr 16, 2026 Started: Oct 1, 2012 Primary completion: Apr 21, 2017 Completion: Oct 1, 2017
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Recruitment defect

This observational or N/A phase trial investigates Breast Cancer and is currently terminated or withdrawn. Institut Paoli-Calmettes leads this study, which shows 8 recorded versions since 2012 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~Jan 2017 – ~Jul 2017 · 6 months · monthly snapshotRecruiting~Jul 2017 – ~Jun 2018 · 11 months · monthly snapshotTerminated~Jun 2018 – ~Sep 2018 · 3 months · monthly snapshotTerminated~Sep 2018 – ~Jan 2021 · 28 months · monthly snapshotTerminated~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – ~Apr 2026 · 20 months · monthly snapshotTerminatedApr 21, 2026 – present · 4 months · daily APITerminated

Change History

8 versions recorded
  1. Apr 21, 2026 — Present [daily]

    Terminated

    Phase: PHASE3None

  2. Sep 2024 — Apr 2026 [monthly]

    Terminated PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE3

  4. Jan 2021 — Jul 2024 [monthly]

    Terminated PHASE3

  5. Sep 2018 — Jan 2021 [monthly]

    Terminated PHASE3

Show 3 earlier versions
  1. Jun 2018 — Sep 2018 [monthly]

    Terminated PHASE3

  2. Jul 2017 — Jun 2018 [monthly]

    Terminated PHASE3

    Status: RecruitingTerminated

  3. Jan 2017 — Jul 2017 [monthly]

    Recruiting PHASE3

    First recorded

Oct 2012

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

The acute pain care, in particular after breast cancer surgery must be early and quickly effective, because a severe postoperative pain increases the risk of chronic pain and exposes to a risk of important embarrassment for the realization of simple daily movements. Associated to conventional analgesics administered by systemic way, a local anesthesic (ropivacaine) can be continuously infused (Continues Cicatricial Perfusion CCP) in the operating wound by a multi-drilled catheter by means of a elastomeric diffuser set up in the surgical unit by the surgeon at the end the surgical procedure. Besides the control of the postoperative acute pain, the local anesthesic could intervene in the prevention of the chronic pain, the early recovery, the reduction of the neuropathic pains and the decrease of needs in morphine after mastectomy. The duration of hospitalization being lower than 48 hours for this type of surgery, the investigators envisage an immediate follow-up in the Units of Care then at home, what will require a training of the hospital actors and at home (patient, family, visiting nurse, general practitioner). Although proposed for several years, the CCP after breast surgery is still a little spread technique and few works had evaluated the pain at rest and at mobilization after mastectomy, the early rehabilitation, and to spread its use towards home, that is why we propose a randomized double-blind study ropivacaine / placebo in patients after mastectomy.

Contact Information

Sponsor contact:
  • Institut Paoli-Calmettes
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations