A Phase 3 interventional study of Ropivacaine and physiological saline in Breast Cancer, sponsored by Institut Paoli-Calmettes. Terminated at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-21.
Sponsored by Institut Paoli-Calmettes · Phase 3, Interventional, and Treatment
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 59 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Institut Paoli-Calmettes is the lead sponsor of 168 studies on the registry; 50 are open to participants now.
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Exclusion Criteria:
Ropivacaine
Drug: Ropivacaine
physiological saline
Drug: physiological saline
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
a bolus of 10 ml of physiological saline in the catheter of multi- drilled cicatricial perfusion
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 frame: 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).
pain intensity
postoperative global and neuropathic pain scale
Time frame: 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
\- Consumption of analgesics taken at request, in particular morphine savings in immediate postoperative
Time frame: 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
\- Side effects evaluated according to CTC-AE V4 (COMMON TERMILOLOGY CRITERIA FOR ADVERSE EVENTS version 4)
Time frame: from surgery up to 3 days after the end of treatment
quality of life evaluation
\- Satisfaction and quality of life of the patients evaluated by scale and questionaries (QLQ-C30)at inclusion, month 1, month 3.
Time frame: 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).
This study is terminated, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Institut Paoli-Calmettes