Clinical trial · Interventional
Wound Infiltration and Breast Cancer Surgery
Double Blind Randomized Trial of Wound Infiltration With Ropivacaine After Breast Cancer Surgery
NCT01404377CI-TRIAL-00005293completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Prospective double blind randomized evaluation of the effect of surgical wound infiltration with ropivacaine versus placebo in patients scheduled for breast surgery with axillary lymph node dissection
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| infiltration with ropivacaine solution | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- ropivacaine
- description
- treated group (ropivacaine infiltration)
- interventionNames
- Procedure: infiltration with ropivacaine solution
- type
- PLACEBO_COMPARATOR
- label
- placebo
- description
- placebo group : infiltration with saline solution
- interventionNames
- Procedure: infiltration with ropivacaine solution
Primary outcomes (1)
- measure
- 30% decrease in VAS score on mobilization on the day of surgery
- timeFrame
- patients will be followed during all the duration of hospital stay and 2 months after surgery
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult ASA I - II patients, scheduled for unilateral mastectomy or tumorectomy associated with axillary lymph node dissection Exclusion Criteria: * Patients receiving opioid or any other analgesic treatment for chronic pain before surgery, patients with known allergy to local anaesthetics, and patients with acquired or genetic haemostatic abnormality
References
Publications (1)
- DERIVEDVigneau A, Salengro A, Berger J, Rouzier R, Barranger E, Marret E, Bonnet F. A double blind randomized trial of wound infiltration with ropivacaine after breast cancer surgery with axillary nodes dissection. BMC Anesthesiol. 2011 Nov 24;11:23. doi: 10.1186/1471-2253-11-23. PMID 22114900