Immediate and Chronic Pain After Mastectomy Managed With PECS Block or Local InfiltrationNCT04443894
Acute & Chronic Post-mastectomy Pain: Can PECS Block Alter the Geography?
A study testing PECS block and local infiltration in people with Immediate and Chronic Pain After Mastectomy Managed With PECS Block or Local Infiltration, run by Attikon Hospital at 1 site in Greece.
Trial summary
Post mastectomy pain management is of crucial importance for patients' rehabilitation and quality of life. PECS block is used for acute and chronic post mastectomy pain management. Surgical infiltration is also used in this field. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Immediate and Chronic Pain After Mastectomy Managed With PECS Block or Local Infiltration
- What is being tested?
- PECS block and local infiltration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGreece
- Study dates
- 20 May 2020to 31 Dec 2023
- Phase
- Interventional
- 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
- over 18 years of age
- ASA physical status I-III
- elective partial mastectomy
Who cannot join
- refusal of patient participation or inability to participate to the study
- known allergic reaction to drugs included in the study design
- contraindiations of performance of peripheral regional anesthesia
- diabetes melitus or known neurological disorder
- chronic pain disorders under therapy with opioids or other analgesic drugs for chronic pain
- all male patients
- all patients not speaking the Greek language
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.
Athens, 12462
Chrysanthi Batistaki, MD, PhD, 0030 210 5832371, chrysabatistaki@yahoo.gr
About this study
Post mastectomy pain management is of crucial importance for patients' rehabilitation and quality of life. PECS block is used for acute and chronic post mastectomy pain management. Surgical infiltration is also used in this field. Patients in our study are divided in two groups receiving PECS block or surgical infiltrationbefore incision. Multimodal analgesia is indispensable according to recent guidelines for enhanced postoperative recovery. Pain scores will be assessed during the first 24h postoperatively and at 3 months after surgery.
Read the detailed description
Patients are randomly assigned to 2 groups, PECS block or surgical infiltration group. Patients assigned to PECS group will receive 30cc of ropivacaine 0,375% where 10cc will be injected between pectoralis major and pectoralis minor and 20cc between pectoralis minor and serratus anterior muscle under ultrasound guidance. Patients assigned to surgical infiltration group will receive 30cc of ropivacaine 0,375% injected by the surgeon. Local aneshetic is administered in both groups after the induction of general anesthesia and before incision. Pain will be assessed at 1, 12, 24h after surgery and at three months after surgery communicating by telephone. Post operative analgesia includes paracetamol 1gr, parecoxib 40 mg (as required) and tramadol as rescue analgesia (1 mg/kg iv up to 3 times daily). Chronic pain will be assessed after 3 months as for prevalence and neuropathic characteristics.
- Being tested
- PECS block, local infiltration
- Keywords
- pain, mastectomy, PECS
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PECS blockOther
PECS block is performed at the side of surgery (II) before incision with ropivacaine 0,375%.(30 ml). General anesthesia is induced and maintained with midazolam, fentanyl, propofol and rocuronium. Pain is assessed postoperatively according to protocol (24 hours and after 3 months).
local infiltrationOther
local infiltration of the surgical wound before incision with πwith ropivacaine 0,375%.(30 ml). General anesthesia is induced and maintained with midazolam, fentanyl, propofol and rocuronium. Pain is assessed postoperatively according to protocol (24 hours and after 3 months).
| Study group | Role | What they receive |
|---|---|---|
| PECS block | Active comparator | Not described Receives: Other: PECS block |
| local infiltration | Active comparator | Not described Receives: Other: local infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
intensity of acute postoperative pain
intensity of acute postoperative pain, numeric rating scale 0-10
Measured: 24 hours
Secondary outcomes (3)
intensity of chronic pain
intensity of chronic pain with numeric rating scale 0-10
Measured: 3 months
Prevalence of chronic neuropathic pain
Prevalence of chronic pain at the site of surgery, measured with the LANSS questionnaire
Measured: 3 months
Prevalence of chronic neuropathic pain
Prevalence of chronic pain at the site of surgery, measured with YES./NO
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start20 May 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immediate and Chronic Pain After Mastectomy Managed With PECS Block or Local InfiltrationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chrysanthi Batistaki, Attikon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04443894
- Sponsor's protocol ID
- BreastPecs
- Status last verified
- Jun 2020
- First submitted
- 21 Jun 2020
- Last updated
- 23 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute & Chronic Post-mastectomy Pain: Can PECS Block Alter the Geography?
- ClinicalTrials.gov ID
- NCT04443894
- Acronym / sponsor ID
- BreastPecs
- Keywords
- pain, mastectomy, PECS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Study start
- 20 May 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 23 Jun 2020 (actual)
- 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.
Post mastectomy pain management is of crucial importance for patients' rehabilitation and quality of life. PECS block is used for acute and chronic post mastectomy pain management. Surgical infiltration is also used in this field. Patients in our study are divided in two groups receiving PECS block or surgical infiltrationbefore incision. Multimodal analgesia is indispensable according to recent guidelines for enhanced postoperative recovery. Pain scores will be assessed during the first 24h postoperatively and at 3 months after surgery.
Detailed description
Patients are randomly assigned to 2 groups, PECS block or surgical infiltration group. Patients assigned to PECS group will receive 30cc of ropivacaine 0,375% where 10cc will be injected between pectoralis major and pectoralis minor and 20cc between pectoralis minor and serratus anterior muscle under ultrasound guidance. Patients assigned to surgical infiltration group will receive 30cc of ropivacaine 0,375% injected by the surgeon. Local aneshetic is administered in both groups after the induction of general anesthesia and before incision. Pain will be assessed at 1, 12, 24h after surgery and at three months after surgery communicating by telephone. Post operative analgesia includes paracetamol 1gr, parecoxib 40 mg (as required) and tramadol as rescue analgesia (1 mg/kg iv up to 3 times daily). Chronic pain will be assessed after 3 months as for prevalence and neuropathic characteristics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PECS block | Active comparator | Other: PECS block |
| local infiltration | Active comparator | Other: local infiltration |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- over 18 years of age
- ASA physical status I-III
- elective partial mastectomy
Key exclusion criteria (7 listed)
- refusal of patient participation or inability to participate to the study
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 |
|---|---|---|
| PECS blockPECS block is performed at the side of surgery (II) before incision with ropivacaine 0,375%.(30 ml). General anesthesia is induced and maintained with midazolam, fentanyl, propofol and rocuronium. Pain is assessed postoperatively according to protocol (24 hours and after 3 months). | Other | PECS block |
| local infiltrationlocal infiltration of the surgical wound before incision with πwith ropivacaine 0,375%.(30 ml). General anesthesia is induced and maintained with midazolam, fentanyl, propofol and rocuronium. Pain is assessed postoperatively according to protocol (24 hours and after 3 months). | Other | local infiltration |
Primary outcome
intensity of acute postoperative pain
Time frame: 24 hours
intensity of acute postoperative pain, numeric rating scale 0-10
3 secondary outcomes
intensity of chronic pain
Time frame: 3 months
Prevalence of chronic neuropathic pain
Time frame: 3 months
Prevalence of chronic neuropathic pain
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2020.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PECS block and local infiltration in people with Immediate and Chronic Pain After Mastectomy Managed With PECS Block or Local Infiltration, run by Attikon Hospital at 1 site in Greece.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 23 Jun 2020. 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 Greece. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eleftheria Soulioti, MD,PhD (00306946745366, eleftheriasoulioti@ymail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intensity of acute postoperative pain (time frame: 24 hours). 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 23 Jun 2020.