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

NCT02525211 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2026-04-21

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Ropivacaine

a bolus of 10 ml of ropivacaine 7,5 mg / l then by a diffuser of local anesthesic (Ropivacaine 2mg / ml in continuous flow 10ml / hour) connected on the catheter the day after the intervention before returning at home

DRUG

physiological saline

a bolus of 10 ml of physiological saline in the catheter of multi- drilled cicatricial perfusion

Sponsors & Collaborators

  • Institut Paoli-Calmettes

    lead OTHER

Principal Investigators

  • Daniel FRANCON, MD · Institut Paoli-Calmettes

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2017-04-21
Completion
2017-10-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02525211 on ClinicalTrials.gov