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

NCT02525211 | Terminated Phase 3

• 1 other identifier: DOLOSEIN / IPC 2011-005
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Delay to obtain the three criteria of premature recovery after mastectomy

  Delay to obtain the three criteria of premature recovery after mastectomy until 3 months post surgery:satisfactory analgesia defined by a Digital Scale lower than 4, estimated at rest and after standardized mobilization in immediate postoperative, and recourses or not to an analgesia of help, and capacity to drink with a glass and to thread the sleeve of a garment with the member side of the operated breast.

  time from surgery up to 6 months (At day of surgery, and at day 1, day 2, day 3 and day 15, then at month 3 and month 6).

Secondary Outcomes (4)

• pain intensity

  time from surgery up to 6 months (At day of surgery, and at day 1, day 2, day 3 and day 15, then at month 3 and month 6).

• Analgesics consumption measure

  time from surgery up to 3 months (At day of surgery, and at day 1, day 2, day 3 and day 15, then at month 3 and month 6).

• Measure of side effects rate

  from surgery up to 3 days after the end of treatment

• quality of life evaluation

  time from surgery up to 3 months (At day of surgery, and at day 1, day 2, day 3 and day 15, then at month 1 and month 3).

Study Arms (2)

Ropivacaine

EXPERIMENTAL

Ropivacaine

Drug: Ropivacaine

placebo

PLACEBO COMPARATOR

physiological saline

Drug: physiological saline

Interventions

Ropivacaine 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

Ropivacaine

physiological saline DRUG

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

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead

Study Sites (1)

Daniel FRANCON

Marseille, 13009, France

Location

Related Publications (1)

• Riff C, Guilhaumou R, Marsot A, Beaussier M, Cohen M, Blin O, Francon D. Ropivacaine Wound Infiltration for Pain Management After Breast Cancer Mastectomy: A Population Pharmacokinetic Analysis. Clin Pharmacol Drug Dev. 2018 Nov;7(8):811-819. doi: 10.1002/cpdd.452. Epub 2018 Apr 16.

  PMID: 29659182 RESULT

Related Links

• official web site of the sponsor

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Daniel FRANCON, MD

  Institut Paoli-Calmettes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2012
• First Posted: August 17, 2015
• Study Start: October 1, 2012
• Primary Completion: April 21, 2017
• Study Completion: October 1, 2017
• Last Updated: April 21, 2026

Record last verified: 2018-08

Locations

FR (1)