MIRs 04 : Interpectoral Nerve Block With Ropivacaine Versus Placebo Before Breast Cancer Surgery
Study Details
Study Description
Brief Summary
Compare the effect of ropivacaine versus placebo pectoral nerve block (Pecs 1 and 2) on acute pain after tumorectomy plus sentinel lymph node dissection on one day surgery.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Detailed Description
Before surgery, the 3rd interpectoral space will be identified. After aspiration, half of the solution of Ropivacaine 5 mg/ml not exceeding 3 mg/kg of maximal dose and 30 ml of maximal volume or saline (not exceeding 30 ml of maximal volume) will be injected into the interpectoral space underneath the pectoralis major muscle for the Pecs 1 block. The other half of the solution will be injected above the serratus anterior muscle at the third rib.
Evaluation of the percentage of patients treated with step 2 or 3 analgesics during the three postoperative hours.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo Saline (30 mL maximum) |
Drug: Saline
Injection of the solution of Saline not exceeding 30 mL of maximal volume.
Other Names:
|
| Experimental: Ropivacaïne Ropivacaïne 5 mg/mL (not to exceed 3 mg/kg and 30 ml of maximal volume) |
Drug: Ropivacaine
Dilution of Ropivacaine 7.5 mg/ml to 5 mg/ml not to exceed 3 mg/kg of maximal dose and 30 ml of maximal volume
Other Names:
|
Outcome Measures
Primary Outcome Measures
- To compare the effect of ropivacaine versus placebo pectoral nerve block (Pecs 1 and 2) on acute pain after tumorectomy plus sentinel lymph node dissection on one day surgery [3 hours]
Percentage of patients treated with step 2 or 3 analgesics during the first three postoperative hours after tumorectomy plus sentinel lymph node dissection, between the group with Ropivacaïne and the group with placebo
Secondary Outcome Measures
- Evaluation of acute pain at rest and after shoulder movement until 48 postoperative hours [48 hours]
VAS Scale (0 to 10 : 0 = no pain and 10 = Worst pain possible) at rest and after shoulder movement every 30 minutes during the first three postoperative hours in the PACU and the day surgery unit and then at home every 6 hours for the first 48 postoperative hours .
- Evaluation of acute pain until 48 postoperative hours [48 hours]
Brief Pain Inventory Questionnaires at 48 hours will be collected with VAS Scale (0 to 10 : 0 = no pain and 10 = Worst pain possible)
- Evaluation of patient's satisfaction on pain management [48 hours]
Scale of satisfaction ( 0 to 10 : 0 = very bad and 10 = excellent) of the pain management at 48 post-operative hours
- Evaluation of Remifentanil consumption during anesthesia [3 hours]
Total dose of Remifentanil during anesthesia for a bispectral index between 40-60 or Analgesia Nociception Index (ANI) > 60%
- Evaluation of analgesic consumption during the first 48 postoperative hours [48 hours]
Consumption of Ketoprofene in systematic, Paracetamol if VAS>3 and Tramadol if analgesia is not enough during 48 postoperative hours
- Evaluation of the incidence of nausea and vomiting during the first 48 postoperative hours [48 hours]
Incidence of nausea and vomiting during the first 48 postoperative hours
- Evaluation of complications of Pecs during 48 postoperative hours [48 hours]
Complications of Pecs block: pneumothorax, nerve injury, hypotension, vascular puncture and systemic toxicity of local anaesthetic (seizures, etc.) collected
- Evaluation of the incidence of serious adverse events during 30 days [30 days]
Number of serious adverse events during 30 days after Pecs administration
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Women with non-metastatic invasive breast carcinoma or breast carcinoma in situ treated by breast-conserving surgery (tumorectomy) with sentinel node technique on one day surgery.
-
Age between 18 and 85 years.
-
ASA class 1, 2 or 3
-
Signed informed consent form.
Exclusion Criteria:
-
Ongoing neoplasm or history of neoplasm other than breast cancer with the exception of: basal cell carcinoma, cervical carcinoma in situ, other treated cancer that has not relapsed during the 5 years preceding inclusion in the trial.
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Axillary dissection planned during surgery planning
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All bilateral surgery the day of Pecs administration
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Metastatic breast carcinoma at diagnosis (M1).
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Allergy to local anesthetics and morphine.
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Use of analgesics during the 12 hours preceding the surgical procedure.
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History of ipsilateral surgery during the previous 6 months.
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History of substance abuse.
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Pregnant woman or breastfeeding.
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Subjects deprived of their liberty or under guardianship (including temporary guardianship).
-
Subjects no covered by social security scheme
-
Experiencing any psychiatric condition or major cognitive impairment that may hamper completion of self-reported questionnaires.
There is no prohibition for people to take part simultaneously in another search and there is no exclusion cause at the end of the research period
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre Jean Perrin | Clermont-Ferrand | France | 63000 | |
| 2 | Institut Curie | Paris | France | 75005 | |
| 3 | Hopital Tenon | Paris | France | 75020 | |
| 4 | Institut de Cancérologie de Lorraine | Vandoeuvre les Nancy | France | 54500 |
Sponsors and Collaborators
- Institut Curie
Investigators
- Study Director: Pierre FUMOLEAU, PhD, Institut Curie
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IC 2019-04