Breast SurgeryNCT04457115
Erector Spinae Plane Block Versus Thoracic Paravertebral Block for Pain Control in Modified Radical Mastectomy
A study testing Thoracic paravertebral block and Erector spinae plane Block in people with Breast Surgery and Thoracic Paravertebral Block, run by AUSL Romagna Rimini at 1 site in Italy.
Trial summary
The aim of the study is to compare the effectiveness of the Erector spinae plane (ESP) block versus thoracic paravertebral (TPV) block in the post-operative pain control after radical mastectomy. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Breast Surgery, Thoracic Paravertebral Block, Post-operative Pain Control
- What is being tested?
- Thoracic paravertebral block and Erector spinae plane Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteItaly
- Study dates
- 27 Apr 2020to 15 Nov 2021
- 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
- Patients aged between 18 and 85
- American Society of Anesthesiologists classification I - III
- Signature of consent to participate in the study
Who cannot join
- Coagulopathies and / or use of antiplatelet / anticoagulant drugs
- Infections and/or lesions at the puncture site,
- BMI ≥40
- allergies and / or contraindications to the administration of the drugs used in the study,
- use of chronic opioid therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Efficacy of Ultrasound-guided Erector Spinae Plane Block Versus Thoracic Paravertebral Block for Intra and Postoperative Pain Control in Modified Radical Mastectomy: a Randomized Controlled Trial.
The aim of the study is to compare the effectiveness of the Erector spinae plane (ESP) block versus thoracic paravertebral (TPV) block in the post-operative pain control after radical mastectomy.
Read the detailed description
Primary outcome of our study is to compare the effectiveness of two regional anesthesia techniques, ESP block and TPV block, in the post-operative pain-control after radical mastectomy.
We will also evaluate both intra and post-operative opioid consumption, the incidence of PONV, the length of hospital stay, patient satisfaction with the anesthesiology technique and the incidence of chronic pain 6 months after surgery.
- Conditions
- Breast Surgery, Thoracic Paravertebral Block, Post-operative Pain Control, Erector Spinae Plane Block, Opioid Use
- Being tested
- Thoracic paravertebral block, Erector spinae plane Block
- Keywords
- breast surgery, Thoracic paravertebral block, Erector spinae plane block, Mastectomy, post-operative pain control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic paravertebral blockProcedure or surgery
Thoracic paravertebral block performed at T2-T3 and T4-T5 levels with administration of Ropivacaine 0.7% 8 ml for each level
Erector spinae plane BlockProcedure or surgery
Erector spinae plane block performed at T2 and T5 levels with administration of Ropivacaine 0.5% 12 ml for each level
| Study group | Role | What they receive |
|---|---|---|
| TPV Block | Experimental | Thoracic paravertebral block performed at thoracic level T2-T3 and T4-T5 with administration of Ropivacaine 0.7% 8 ml for each level. Receives: Procedure: Thoracic paravertebral block |
| ESP Block | Experimental | Erector spinae plane block performed at thoracic level T2 and T5 with administration of Ropivacaine 0.5% 12 ml for each level. Receives: Procedure: Erector spinae plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain assessment
post-operative pain assessment using Numeric rating scale (from 0,no pain, to 10 ,worst pain)
Measured: 12 hours
Secondary outcomes (5)
Length of hospital stay
The number of days of hospitalization after surgery will be assessed
Measured: 3 days
Evaluate the incidence and severity of persistent pain 6 months after surgery
Evaluate the incidence and severity of persistent pain 6 months after surgery using Numeric rating scale (from 0, no pain, to 10, worst pain)
Measured: six months
Opioid use
Intra and post-operative opioid use
Measured: 36 hours
Incidence of PONV
Incidence of post operative nausea and vomiting (PONV) in the first 36 hours
Measured: 36 hours
Assessment of patient satisfaction with the anesthesiological technique
Patients is requested to fill out a pre-printed sheet on their judgment of the anesthesiological procedure, in which they can express a value from 0 to 5, where 0 indicates "entirely dissatisfied" and 5 indi- cates "very satisfied"
Measured: 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start27 Apr 2020
- Primary completion30 Sep 2021
- Study completion15 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- AUSL Romagna Rimini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Domenico P Santonastaso, MD, Principal investigator, AUSL Romagna, M. Bufalini Hospital, Cesena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04457115
- Sponsor's protocol ID
- ELETTRA
- Other IDs
- 2613
- Status last verified
- Nov 2021
- First submitted
- 22 Jun 2020
- Last updated
- 18 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Santonastaso DP, de Chiara A, Righetti R, Marandola D, Sica A, Bagaphou CT, Rosato C, Tognu A, Curcio A, Lucchi L, Russo E, Agnoletti V. Efficacy of bi-level erector spinae plane block versus bi-level thoracic paravertebral block for postoperative analgesia in modified radical mastectomy: a prospective randomized comparative study. BMC Anesthesiol. 2023 Jun 16;23(1):209. doi: 10.1186/s12871-023-02157-2.
PubMed 37328817
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Ultrasound-guided Erector Spinae Plane Block Versus Thoracic Paravertebral Block for Intra and Postoperative Pain Control in Modified Radical Mastectomy: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04457115
- Acronym / sponsor ID
- ELETTRA
- Conditions
- Breast Surgery, Thoracic Paravertebral Block, Post-operative Pain Control, Erector Spinae Plane Block, Opioid Use
- Keywords
- breast surgery, Thoracic paravertebral block, Erector spinae plane block, Mastectomy, post-operative pain control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- AUSL Romagna RiminiUniversity, hospital or other
- Study start
- 27 Apr 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 15 Nov 2021 (actual)
- First posted
- 7 Jul 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.
The aim of the study is to compare the effectiveness of the Erector spinae plane (ESP) block versus thoracic paravertebral (TPV) block in the post-operative pain control after radical mastectomy.
Detailed description
Primary outcome of our study is to compare the effectiveness of two regional anesthesia techniques, ESP block and TPV block, in the post-operative pain-control after radical mastectomy.
We will also evaluate both intra and post-operative opioid consumption, the incidence of PONV, the length of hospital stay, patient satisfaction with the anesthesiology technique and the incidence of chronic pain 6 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TPV Block | Experimental | Procedure: Thoracic paravertebral blockThoracic paravertebral block performed at thoracic level T2-T3 and T4-T5 with administration of Ropivacaine 0.7% 8 ml for each level. |
| ESP Block | Experimental | Procedure: Erector spinae plane BlockErector spinae plane block performed at thoracic level T2 and T5 with administration of Ropivacaine 0.5% 12 ml for each level. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged between 18 and 85
- American Society of Anesthesiologists classification I - III
- Signature of consent to participate in the study
Key exclusion criteria (5 listed)
- Coagulopathies and / or use of antiplatelet / anticoagulant drugs
- Infections and/or lesions at the puncture site,
- BMI ≥40
- allergies and / or contraindications to the administration of the drugs used in the study,
- use of chronic opioid therapy
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 |
|---|---|---|
| Thoracic paravertebral blockThoracic paravertebral block performed at T2-T3 and T4-T5 levels with administration of Ropivacaine 0.7% 8 ml for each level | Procedure or surgery | TPV Block |
| Erector spinae plane BlockErector spinae plane block performed at T2 and T5 levels with administration of Ropivacaine 0.5% 12 ml for each level | Procedure or surgery | ESP Block |
Primary outcome
Post-operative pain assessment
Time frame: 12 hours
post-operative pain assessment using Numeric rating scale (from 0,no pain, to 10 ,worst pain)
5 secondary outcomes
Length of hospital stay
Time frame: 3 days
Evaluate the incidence and severity of persistent pain 6 months after surgery
Time frame: six months
Opioid use
Time frame: 36 hours
Incidence of PONV
Time frame: 36 hours
Assessment of patient satisfaction with the anesthesiological technique
Time frame: 36 hours
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 18 Nov 2021.
- Derived from this study: PubMed 37328817Santonastaso DP, de Chiara A, Righetti R, Marandola D, Sica A, Bagaphou CT, Rosato C, Tognu A, Curcio A, Lucchi L, Russo E, Agnoletti V. Efficacy of bi-level erector spinae plane block versus bi-level thoracic paravertebral block for postoperative analgesia in modified radical mastectomy: a prospective randomized comparative study. BMC Anesthesiol. 2023 Jun 16;23(1):209. doi: 10.1186/s12871-023-02157-2.
- 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.
Domenico P Santonastaso, MD principal investigator
AUSL Romagna, M. Bufalini Hospital, Cesena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic paravertebral block and Erector spinae plane Block in people with Breast Surgery and Thoracic Paravertebral Block, run by AUSL Romagna Rimini 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 3 inclusion and 5 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 18 Nov 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 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 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?
Post-operative pain assessment (time frame: 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04457115, which also lists 1 linked publication.
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 18 Nov 2021.