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

NCT ID: NCT02525211

Last Updated: 2018-08-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2017-10-31

Brief 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

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Ropivacaine

Ropivacaine

Group Type: EXPERIMENTAL

Ropivacaine

Intervention Type: DRUG

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

placebo

physiological saline

Group Type: PLACEBO_COMPARATOR

physiological saline

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

physiological saline

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Women > 18 years,
• Operated for a breast cancer by mastectomy with or without lymph node dissection, without immediate reconstruction,
• Capable of understanding the antalgic protocol,
• No contraindication to the local anesthesics,
• Social security affiliation,
• Signed informed consent.

Exclusion Criteria

• Preoperative radiotherapy,
• Local infection,
• Contra-indication to the local anesthetic or to CCP,
• Contra-indication for the use of morphine,
• Contra-indication for the use of remifentanil,
• Addiction to opioid analgesics know or not,
• Allergy to local anesthetics,
• Hepatic or renal impairment grim known,
• Previous surgery on the operated breast,
• Pregnant women, or child-bearing potential, or lactating women,
• Patient deprived of liberty or under supervision of a guardian.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institut Paoli-Calmettes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel FRANCON, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Paoli-Calmettes

Locations

Daniel FRANCON

Marseille, , France

Countries

France

Related Links

http://www.institutpaolicalmettes.fr

official web site of the sponsor

Other Identifiers

DOLOSEIN / IPC 2011-005

Identifier Type: -

Identifier Source: org_study_id