Locoregional Analgesia in Breast Surgery Clinical Trial
— DESIGNOfficial title:
A Randomised, Double-blind, Placebo-controlled Study to Assess the effectIveness of Pectoral Nerves Block (PECS) After Breast Surgery on Piritramide Consumption
| Verified date | January 2021 |
| Source | Jules Bordet Institute |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The aims of this study is to compare the effectiveness of pecs block associated to a general anesthesia in terms of Piritramide consumption compared with a general anaesthesia alone and the chronic pain incidence in patients that undergoing either a lumpectomy or a mastectomy associated with axillary dissection This is a double-blind, placebo controlled study that will randomise breast cancer subjects in 1:1 ratio to receive a "pecs block" of Ropivacaine 3.5 mg/ml and Clonidine 5 µg/ml (arm A) versus placebo (arm B).
| Status | Completed |
| Enrollment | 54 |
| Est. completion date | January 20, 2021 |
| Est. primary completion date | November 2019 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: 1. Age =18 years old 2. Female 3. Subjects undergoing either a conservative or non-conservative breast surgery associated with axillary dissection 4. ASA score = 3 5. Completion of all necessary screening procedures within 30 days prior to randomisation 6. Adequate Renal Function including: Serum creatinine = 1.5 x upper limit of normal (ULN) or estimated creatinine clearance = 60 ml/min as calculated using the method standard for the institution 7. Adequate Liver Function, including all of the following parameters: 1. Aspartate and Alanine Aminotransferase (AST and ALT) = 1.5 x ULN If Aspartate and Alanine aminotransferase (AST and ALT) are > 1.5 x ULN, total serum bilirubin should be assessed and must be = 1.5 x ULN unless the patient has documented Gilbert Syndrome 2. Alkaline phosphatase = 2.5 x ULN 8. Signed informed consent 9. Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures Exclusion criteria: 1. Any illness or medical condition that is unstable or could jeopardize the safety of the patient or her compliance with study requirements 2. Allergy to local anaesthetics 3. Known allergy or hypersensitivity to Paracetamol, Diclofenac, Piritramide or excipients 4. Coagulopathy or taking oral anticoagulant/ antiaggregant within 7 days prior to surgery 5. BMI> 35 kg / m2 6. Infection near the puncture site 7. Inability to understand the pain assessment scales (VAS and McGill questionnaire) 8. Severe hepatic impairment: elevated transaminases with factor V = 50% 9. Severe heart failure: NYHA classification III or IV and/or LVEF < 50% 10. Pregnant or lactating women 11. Concurrent treatment with daily basis chronic opiate type painkillers not ended 1 month prior surgery 12. Scheduled breast reconstruction at the time of surgery 13. Metastatic subjects 14. Subjects with breast implants 15. Patients that require bilateral mastectomy or bilateral lumpectomy |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Institut Jules Bordet | Bruxelles |
| Lead Sponsor | Collaborator |
|---|---|
| Jules Bordet Institute |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evaluation of the effectiveness of pecs block in terms of total Piritramide consumption | Piritramide consumption in the first 24 h post-surgery will be recorded | 24 hrs post-surgery | |
| Secondary | Evaluation of incidence of chronic pain in both groups at 6 months postoperatively | Pain intensity until 6 months post-surgery will be evaluated using the Short version of Mc Gill questionnaire (SF-MPQ2) | 6 months post-surgery | |
| Secondary | Evaluation of present pain post-operatively | Present pain intensity until 48 hrs post- surgery will be assessed by Visual Analog scoring | 48 hours post-surgery |