Breast CancerNCT03811262
Comparison of Erector Spinae Plane Block With PECS II Block in Patients Undergoing Breast Cancer Surgery
A study testing ESP BLOCK and PECS BLOCK in people with Breast Cancer and Anesthesia, Local, run by University of Padova at 1 site in Italy.
Trial summary
Backgroung:Regional anesthesia in breast surgery is of paramount importance to reduce pain in perioperative period. PECS II block is an interfascial block that has been used widely as regional anesthesia technique in breast surgery. ESP block is a novel interfascial block proposed in 2016 by Forero. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Breast Cancer, Anesthesia, Local
- What is being tested?
- ESP BLOCK and PECS BLOCK
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2022to Jan 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mastectomy program with axillary clearence
Who cannot join
- bilateral surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Erector Spinae Plane Block With PECS II Block in Patients Undergoing Breast Cancer Surgery:a Randomized Controlled Trial
Backgroung:Regional anesthesia in breast surgery is of paramount importance to reduce pain in perioperative period.
PECS II block is an interfascial block that has been used widely as regional anesthesia technique in breast surgery.
ESP block is a novel interfascial block proposed in 2016 by Forero. Several reports used this technique in breast surgery to provide analgesia but to date no studies comparing these technique exists.
Our hypotesis is that this two technique are equally able to provide analgesia in breast surgery.
Study type: RCT, single blind.
- Conditions
- Breast Cancer, Anesthesia, Local
- Being tested
- ESP BLOCK, PECS BLOCK
- Keywords
- PECS, ESP, RCT
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESP BLOCKProcedure or surgery
local anesthetic will be injected between transverous process and erector spinae muscle
PECS BLOCKProcedure or surgery
Also called 30 ml 0.25% Levobupivacaine
local anesthetic will be injected between pectoralis minor and pectoralis major (10 ml) and between pectoralis minor and serratus (20 ml)
| Study group | Role | What they receive |
|---|---|---|
| ESP BLOCK | Active comparator | Intervention:30 ml of 0.25% Levobupivacaine where: ESP block as described by Forero at T5 level (single injection between transversour process and erector spinae muscles) Receives: Procedure: ESP BLOCK |
| PECS block | Active comparator | Intervention:30 ml of 0.25% Levobupivacaine where:PECS II block as described by Blanco. Receives: Procedure: PECS BLOCK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Fentanyl consumption
Intraoperative fentanyl dose (mcg) difference between ESP group and PECS group.
Measured: Intraoperative
Secondary outcomes (9)
NRS at 6 hour
NRS (0-10) difference at sixth postoperative hour between ESP group and PECS group
Measured: sixth postoperative hour
NRS at 12 hour
NRS (0-10) difference at twelth postoperative hour between ESP group and PECS group
Measured: twelth postoperative hour
NRS at 24 hour
NRS (0-10) difference at twentyfourth postoperative hour between ESP group and PECS group
Measured: twentyfourth postoperative hour
Patient satisfaction at 24 hour
Patient satisfaction (0-10) difference regarding anesthesia management at twentyfourth postoperative hour between ESP group and PECS group
Measured: postoperative period (24h)
Time to first opioid consumption in the postoperative period
Time (minutes) to first opioid consumption in the postoperative period
Measured: postoperative period (24h)
Postoperative morphine consumption
postoperative morphine dose (mg) difference between ESP group and PECS group.
Measured: postoperative period (24h)
Nausea and vomit incidence
Incidence of nausea and vomiting in postoperative period
Measured: postoperative period (24h)
Other complication incidence
Incidence of other complcations linked to anesthesia in postoperative period
Measured: postoperative period (24h)
Intraoperative Fentanyl consumption(mcg/kg/h)
Intraoperative fentanyl dose (mcg/kg/h) difference between ESP group and PECS group.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start1 Jan 2022 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionJan 2023 (estimated)
Why it stopped: Logistic reasons (Operating room performing the surgery investigated moved to another structure)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Model description
- This is a single-centre, prospective; double blinded randomised interventional clinical trial. Patients will be randomly allocated to group "PECS" or "ESP" using a closed envelope technique. Group "PECS" will receive PECS II block as described by Blanco using 30 ml Levobupivacaine 0.25% Group "ESP" will receive ESP block as described by forero using 30 ml Levobupivacaine 0.25% at T5 level. Blocks will be executed after general anesthesia induction. All partecipants will receive Fentanyl 2 mcg/kg and Propofol 2 mg/kg for induction. Anesthesia will be mantained with Propofol to obtain a BIS level between 40-50. Patients will receive Fentanyl 33 mcg whenever blood pressure and/or hear rate raise more than 20% from baseline after surgical stimulation. At the end of the surgery patients will receive acetominophen 1 g. postoperative therapy: acetominophen 1g/8hr and ketoprofen 100 mg/12hr. Patients will receive 2 mg Morphine whenever a NRS \> 3.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro De Cassai, University of Padova
- Investigators
- Alessandro De Cassai, MD, Principal investigator, Department of Medicine, DIMED - Section of Anesthesiology and Intensive Care. University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03811262
- Sponsor's protocol ID
- ESPvsPECS/AOP
- Status last verified
- May 2022
- First submitted
- 17 Jan 2019
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Probably data will be shared at the end of the study
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Erector Spinae Plane Block With PECS II Block in Patients Undergoing Breast Cancer Surgery:a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03811262
- Acronym / sponsor ID
- ESPvsPECS/AOP
- Conditions
- Breast Cancer, Anesthesia, Local
- Keywords
- PECS, ESP, RCT
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Logistic reasons (Operating room performing the surgery investigated moved to another structure)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 22 Jan 2019 (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.
Backgroung:Regional anesthesia in breast surgery is of paramount importance to reduce pain in perioperative period.
PECS II block is an interfascial block that has been used widely as regional anesthesia technique in breast surgery.
ESP block is a novel interfascial block proposed in 2016 by Forero. Several reports used this technique in breast surgery to provide analgesia but to date no studies comparing these technique exists.
Our hypotesis is that this two technique are equally able to provide analgesia in breast surgery.
Study type: RCT, single blind.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a single-centre, prospective; double blinded randomised interventional clinical trial. Patients will be randomly allocated to group "PECS" or "ESP" using a closed envelope technique. Group "PECS" will receive PECS II block as described by Blanco using 30 ml Levobupivacaine 0.25% Group "ESP" will receive ESP block as described by forero using 30 ml Levobupivacaine 0.25% at T5 level. Blocks will be executed after general anesthesia induction. All partecipants will receive Fentanyl 2 mcg/kg and Propofol 2 mg/kg for induction. Anesthesia will be mantained with Propofol to obtain a BIS level between 40-50. Patients will receive Fentanyl 33 mcg whenever blood pressure and/or hear rate raise more than 20% from baseline after surgical stimulation. At the end of the surgery patients will receive acetominophen 1 g. postoperative therapy: acetominophen 1g/8hr and ketoprofen 100 mg/12hr. Patients will receive 2 mg Morphine whenever a NRS > 3.
| Arm | Type | Receives |
|---|---|---|
| ESP BLOCK | Active comparator | Procedure: ESP BLOCKIntervention:30 ml of 0.25% Levobupivacaine where: ESP block as described by Forero at T5 level (single injection between transversour process and erector spinae muscles) |
| PECS block | Active comparator | Procedure: PECS BLOCKIntervention:30 ml of 0.25% Levobupivacaine where:PECS II block as described by Blanco. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Mastectomy program with axillary clearence
Key exclusion criteria (1 listed)
- bilateral surgery
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 |
|---|---|---|
| ESP BLOCKlocal anesthetic will be injected between transverous process and erector spinae muscle | Procedure or surgery | ESP BLOCK |
| PECS BLOCKAlso: 30 ml 0.25% Levobupivacainelocal anesthetic will be injected between pectoralis minor and pectoralis major (10 ml) and between pectoralis minor and serratus (20 ml) | Procedure or surgery | PECS block |
Primary outcome
Intraoperative Fentanyl consumption
Time frame: Intraoperative
Intraoperative fentanyl dose (mcg) difference between ESP group and PECS group.
9 secondary outcomes
NRS at 6 hour
Time frame: sixth postoperative hour
NRS at 12 hour
Time frame: twelth postoperative hour
NRS at 24 hour
Time frame: twentyfourth postoperative hour
Patient satisfaction at 24 hour
Time frame: postoperative period (24h)
Time to first opioid consumption in the postoperative period
Time frame: postoperative period (24h)
Postoperative morphine consumption
Time frame: postoperative period (24h)
Nausea and vomit incidence
Time frame: postoperative period (24h)
Other complication incidence
Time frame: postoperative period (24h)
Intraoperative Fentanyl consumption(mcg/kg/h)
Time frame: Intraoperative
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Individual participant dataSharing planned: Undecided. Probably data will be shared at the end of the study
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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.
Alessandro De Cassai, MD principal investigator
Department of Medicine, DIMED - Section of Anesthesiology and Intensive Care. University of Padova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESP BLOCK and PECS BLOCK in people with Breast Cancer and Anesthesia, Local, run by University of Padova at 1 site in Italy.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 23 May 2022. 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 Italy. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Intraoperative Fentanyl consumption (time frame: Intraoperative). 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 May 2022.