Double-blind Study to Assess effectIveness of Pectoral Nerves Block After Breast Surgery on Piritramide Consumption

NCT02655965 | Completed Phase 3

• 3 other identifiers: IJB-SUR-DESIGN-20152015-005574-38CE2483
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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

Locoregional Analgesia in Breast Surgery

Keywords

Breast cancer; lumpectomy; mastectomy; PECS bloc

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Evaluation of incidence of chronic pain in both groups at 6 months postoperatively

  6 months post-surgery

• Evaluation of present pain post-operatively

  48 hours post-surgery

Study Arms (2)

Ropivacaine + Clonidine

EXPERIMENTAL

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.

Drug: Ropivacaine; Drug: Clonidine

Sodium Chloride

PLACEBO COMPARATOR

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.

Drug: Sodium Chloride

Interventions

Ropivacaine DRUG

Ropivacaine 3.5 mg/ml

Ropivacaine + Clonidine

Clonidine DRUG

Clonidine 5µg/ml

Ropivacaine + Clonidine

Sodium Chloride DRUG

Sodium Chloride 0.9 %

Sodium Chloride

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years old
• Female
• Subjects undergoing either a conservative or non-conservative breast surgery associated with axillary dissection
• ASA score ≤ 3
• Completion of all necessary screening procedures within 30 days prior to randomisation
• 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
• Adequate Liver Function, including all of the following parameters:
• 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
• Alkaline phosphatase ≤ 2.5 x ULN
• Signed informed consent
• Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures

You may not qualify if:

• Any illness or medical condition that is unstable or could jeopardize the safety of the patient or her compliance with study requirements
• Allergy to local anaesthetics
• Known allergy or hypersensitivity to Paracetamol, Diclofenac, Piritramide or excipients
• Coagulopathy or taking oral anticoagulant/ antiaggregant within 7 days prior to surgery
• BMI\> 35 kg / m2
• Infection near the puncture site
• Inability to understand the pain assessment scales (VAS and McGill questionnaire)
• Severe hepatic impairment: elevated transaminases with factor V ≤ 50%
• Severe heart failure: NYHA classification III or IV and/or LVEF \< 50%
• Pregnant or lactating women
• Concurrent treatment with daily basis chronic opiate type painkillers not ended 1 month prior surgery
• Scheduled breast reconstruction at the time of surgery
• Metastatic subjects
• Subjects with breast implants
• Patients that require bilateral mastectomy or bilateral lumpectomy

Sponsors & Collaborators

• Jules Bordet Institute: lead

Study Sites (1)

Institut Jules Bordet

Brussels, 1000, Belgium

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Ropivacaine; Clonidine; Sodium Chloride

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Maurice Sosnowski, MD

  Jules Bordet Institute

  STUDY CHAIR

• Kathleen Wiams, MD

  Jules Bordet Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2016
• First Posted: January 14, 2016
• Study Start: May 1, 2016
• Primary Completion: November 1, 2019
• Study Completion: January 20, 2021
• Last Updated: January 27, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)