Clinical trial · Interventional
Double-blind Study to Assess effectIveness of Pectoral Nerves Block After Breast Surgery on Piritramide Consumption
A Randomised, Double-blind, Placebo-controlled Study to Assess the effectIveness of Pectoral Nerves Block (PECS) After Breast Surgery on Piritramide Consumption
NCT02655965CI-TRIAL-00049674DESIGNcompletedPhase 3ClinicalTrials.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)
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).
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 |
|---|---|---|---|
| Locoregional Analgesia in Breast Surgery | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clonidine | Drug | — | UNRESOLVED |
| Ropivacaine | Drug | — | UNRESOLVED |
| Sodium Chloride | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ropivacaine + Clonidine
- description
- A "pecs block" of Ropivacaine 3.5 mg/ml and Clonidine 5 µg/ml will be injected to the patients prior surgery. 10 ml of the drug combination will be injected between pectoral muscles and 20 ml of the drug combination will be injected between the muscles pectoralis minor and serratus anterior. After surgery, subjects in both arms will receive one dose of Paracetamol (1g) and Diclofenac (75 mg) and one dose 0.05 mg/kg Piritramide as well as PCIA (Patient Controlled Intravenous Analgesia)-Piritramide for 24 hrs post-surgery.
- interventionNames
- Drug: Ropivacaine
- Drug: Clonidine
- type
- PLACEBO_COMPARATOR
- label
- Sodium Chloride
- description
- A "pecs block" of Placebo (Sodium Chloride 0.9%) will be injected to the patients prior surgery. 10 ml of the Sodium chloride solution will be injected between pectoral muscles and 20 ml of the Sodium chloride solution will be injected between the muscles pectoralis minor and serratus anterior). After surgery, subjects in both arms will receive one dose of Paracetamol (1g) and Diclofenac (75 mg) and one dose 0.05 mg/kg Piritramide as well as PCIA (Patient Controlled Intravenous Analgesia)-Piritramide for 24 hrs post-surgery.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.