Locoregional Analgesia in Breast SurgeryPhase 3DESIGNNCT02655965
Double-blind Study to Assess effectIveness of Pectoral Nerves Block After Breast Surgery on Piritramide Consumption
A Phase 3 study testing Ropivacaine, Clonidine and Sodium Chloride in people with Locoregional Analgesia in Breast Surgery, run by Jules Bordet Institute at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Locoregional Analgesia in Breast Surgery
- What is being tested?
- Ropivacaine, Clonidine and Sodium Chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteBelgium
- Study dates
- May 2016to 20 Jan 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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
- Being tested
- Ropivacaine, Clonidine, Sodium Chloride
- Keywords
- Breast cancer, lumpectomy, mastectomy, PECS bloc
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Ropivacaine 3.5 mg/ml
ClonidineDrug
Clonidine 5µg/ml
Sodium ChlorideDrug
Sodium Chloride 0.9 %
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Sodium Chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hrs post-surgery
Secondary outcomes (2)
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)
Measured: 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
Measured: 48 hours post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study startMay 2016
- Primary completionNov 2019
- Study completion20 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locoregional Analgesia in Breast SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maurice Sosnowski, MD, Study chair, Jules Bordet InstituteKathleen Wiams, MD, Study chair, Jules Bordet Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02655965
- Sponsor's protocol ID
- IJB-SUR-DESIGN-2015
- Other IDs
- 2015-005574-38, CE2483, 2015
- Acronym
- DESIGN
- Status last verified
- Jan 2021
- First submitted
- 12 Jan 2016
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled Study to Assess the effectIveness of Pectoral Nerves Block (PECS) After Breast Surgery on Piritramide Consumption
- ClinicalTrials.gov ID
- NCT02655965
- Acronym / sponsor ID
- DESIGN / IJB-SUR-DESIGN-2015
- Conditions
- Locoregional Analgesia in Breast Surgery
- Keywords
- Breast cancer, lumpectomy, mastectomy, PECS bloc
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Nov 2019 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 14 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine + Clonidine | Experimental | Drug: Ropivacaine, Drug: ClonidineA "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. |
| Sodium Chloride | Placebo comparator | Drug: Sodium ChlorideA "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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RopivacaineRopivacaine 3.5 mg/ml | Drug | Ropivacaine + Clonidine |
| ClonidineClonidine 5µg/ml | Drug | Ropivacaine + Clonidine |
| Sodium ChlorideSodium Chloride 0.9 % | Drug | Sodium Chloride |
Primary outcome
Evaluation of the effectiveness of pecs block in terms of total Piritramide consumption
Time frame: 24 hrs post-surgery
Piritramide consumption in the first 24 h post-surgery will be recorded
2 secondary outcomes
Evaluation of incidence of chronic pain in both groups at 6 months postoperatively
Time frame: 6 months post-surgery
Evaluation of present pain post-operatively
Time frame: 48 hours post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maurice Sosnowski, MD study chair
Jules Bordet Institute
Kathleen Wiams, MD study chair
Jules Bordet Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ropivacaine, Clonidine and Sodium Chloride in people with Locoregional Analgesia in Breast Surgery, run by Jules Bordet Institute at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the effectiveness of pecs block in terms of total Piritramide consumption (time frame: 24 hrs post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.