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

A Randomised, Double-blind, Placebo-controlled Study to Assess the effectIveness of Pectoral Nerves Block (PECS) After Breast Surgery on Piritramide Consumption

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).

Study Overview

• Status: Completed
• Conditions: Locoregional Analgesia in Breast Surgery
• Intervention / Treatment: Drug: Ropivacaine; Drug: Clonidine; Drug: Sodium Chloride

Detailed Description

This is a double-blind study that will randomise breast cancer subjects in 1:1 ratio to receive a "pecs block" of 10 ml of Ropivacaine 3.5 mg/ml and Clonidine 5 µg/ml injected between pectoral muscles and 20 ml between the muscles pectoralis minor and serratus anterior (arm A) versus 10 ml of placebo (NaCl 0.9%) injected between pectoral muscles and 20 ml between the muscles pectoralis minor and serratus anterior (arm B). The pecs block will inject just before the surgery.

Subjects will receive a nausea and vomiting prophylaxy depending on Apfel score After surgery, the two intervention groups will receive before waking a dose of Paracetamol (1 g) and Diclofenac (75 mg), if they present no contraindications and a dose of 0.05 mg/kg Piritramide .

In the recovery room the two groups will benefit from a Patient Controlled Intravenous Analgesia (PCIA) pump - Piritramide allowing them to control their analgesia, which will be stopped at 24 hours postoperatively.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium, 1000
    • Institut Jules Bordet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ropivacaine + Clonidine; 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; Ropivacaine 3.5 mg/ml; Drug: Clonidine; Clonidine 5µg/ml
Placebo Comparator: Sodium Chloride; 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; Sodium Chloride 0.9 %

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Jules Bordet Institute
• Investigators: Study Chair: Maurice Sosnowski, MD, Jules Bordet Institute; Study Chair: Kathleen Wiams, MD, Jules Bordet Institute

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): November 1, 2019
• Study Completion (Actual): January 20, 2021

Study Registration Dates

• First Submitted: January 12, 2016
• First Submitted That Met QC Criteria: January 13, 2016
• First Posted (Estimate): January 14, 2016

Study Record Updates

• Last Update Posted (Actual): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Breast cancer; mastectomy; lumpectomy; PECS bloc
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Anesthetics, Local; Sympatholytics; Ropivacaine; Clonidine
• Other Study ID Numbers: IJB-SUR-DESIGN-2015; 2015-005574-38 (EudraCT Number); CE2483 (Other Identifier: Institut Jules Bordet)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO