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

NCT ID: NCT02655965

Last Updated: 2021-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2021-01-20

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).

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.

Conditions

Locoregional Analgesia in Breast Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Ropivacaine

Intervention Type: DRUG

Ropivacaine 3.5 mg/ml

Clonidine

Intervention Type: DRUG

Clonidine 5µg/ml

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.

Group Type: PLACEBO_COMPARATOR

Sodium Chloride

Intervention Type: DRUG

Sodium Chloride 0.9 %

Interventions

Ropivacaine

Ropivacaine 3.5 mg/ml

Intervention Type: DRUG

Clonidine

Clonidine 5µg/ml

Intervention Type: DRUG

Sodium Chloride

Sodium Chloride 0.9 %

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jules Bordet Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maurice Sosnowski, MD

Role: STUDY_CHAIR

Jules Bordet Institute

Kathleen Wiams, MD

Role: STUDY_CHAIR

Jules Bordet Institute

Locations

Institut Jules Bordet

Brussels, , Belgium

Countries

Belgium

Other Identifiers

2015-005574-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CE2483

Identifier Type: OTHER

Identifier Source: secondary_id

IJB-SUR-DESIGN-2015

Identifier Type: -

Identifier Source: org_study_id