Other Acute Postoperative PainPhase 4NCT02645474
Is PECS Block Equivalent to Paravertebral Block in Preventing Postoperative Pain After Breast Surgery?
A Phase 4 study testing PECS block with ropivacaine, Paravertebral block with ropivacaine and Ropivacaine in people with Other Acute Postoperative Pain, run by Ospedale Regionale Bellinzona e Valli at 1 site in Switzerland.
Trial summary
Two regional anesthesia techniques already in use in common clinical practice -paravertebral block and pectoral nerve block (PECS block) are compared in a randomized, double-blind, multicenter, controlled, non-inferiority trial, in order to compare their success rate in patients udergoing breast surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Other Acute Postoperative Pain
- What is being tested?
- PECS block with ropivacaine, Paravertebral block with ropivacaine and Ropivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2018to 30 Dec 2023
- Phase
- Phase 4
- 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
- adult patients
- ASA class 1 to 3 patients
- patients scheduled for elective breast mastectomy or quadrantectomy
Who cannot join
- patients' refusal
- contraindication to regional anaesthesia (coagulopathies, concurrent anticoagulant therapy, allergy to local anaesthetics, infection at puncture site)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Ospedale Regionale di Bellinzona e Valli
Bellinzona, 6500
About this study
Official title: Is PECS Block Equivalent to Paravertebral Block in Preventing Postoperative Pain After Breast Surgery? A Randomized, Controlled, Double-blind, Multicenter Trial
Two regional anesthesia techniques already in use in common clinical practice -paravertebral block and pectoral nerve block (PECS block) are compared in a randomized, double-blind, multicenter, controlled, non-inferiority trial, in order to compare their success rate in patients udergoing breast surgery.
Read the detailed description
Aim of the study is to compare paravertebral block and PECS block success rate in patients undergoing elective breast surgery (mastectomy or quadrantectomy) with a combined anesthesia technique.
Primary outcome is block success rate defined as a VAS score of 30 or less in PACU and at 6, 12 and 24 hours after surgery. Secondary outcomes are: rescue opioids requirement; incidence of procedure related complications; incidence of postoperative side-effects; patients' quality of life level during the first 24 postoperative hours; patients' satisfaction.
A prospective, randomized, controlled, double-blinded, non-inferiority trial was designed in order to compare paravertebral block and PECS block with regard to block success over the first 24 hours postoperatively in patients undergoing mastectomy or quadrantectomy procedures with a combined anesthesia technique.
Inclusion criteria: adult patients, ASA class 1 to 3, scheduled for elective mastectomy or quadrantectomy. Exclusion criteria: patients refusal, contraindication to regional anaesthesia (coagulopathies, concurrent anticoagulant therapy, allergy to local anaesthetics, infection at puncture site).
After written informed consent, patients will be randomized into two cohorts, the first being treated with a paravertebral block, while the second with a PECS block. Both procedures will be standardized with regard to injection technique, local anaesthetic drug and volume and performed under ultrasound real-time guidance. Both groups will undergo the regional anesthesia technique after induction of general anaesthesia to be blinded with regard to the type of block. This will be standardized as well, according to our centers current clinical practice. Postoperative pain will be than measured on a validated visual analogue scale (VAS 0-100) in the recovery room and periodically after discharge to the ward until 24 hours postoperatively. Rescue opioids requirement will be recorded. Eventual procedural complications occurred will be recorded as well as postoperative side effects. A questionnaire about patients' satisfaction and quality of life during the first 24 postoperative hours will be filled in for every patient. Data collected will be initially inserted in a form and subsequently collected, pooled and anonymously registered in an electronic data base.
A sample size calculation has been preliminary performed with regard to the primary outcome. A 20% difference in the blocks success rate (defined as a postoperative pain on VAS scale of 30 or less) will be considered as clinically significant.
In our practice, paravertebral block is the current gold standard and it is associated on average to a 50% mean value on VAS scale during the first 48 postoperative hours. PECS block will be thus compared to this standard of care. A total of 39 patients per arm will be required (95% confidence interval). Accounting for a 10% drop-out rate, we will include 43 patients per arm.
Pain levels will be measured as medians and interquartile ranges. Statistical analysis will be performed using Student t-test for normally distributed variables while Mann-Whitney test was applied to non-normally distributed variables.
This study will be conducted in compliance with the protocol, the current version of the Declaration of Helsinki, the ICH-GCP or ISO EN 14155 (as far as applicable) as well as all national legal and regulatory requirements.
- Conditions
- Other Acute Postoperative Pain
- Being tested
- PECS block with ropivacaine, Paravertebral block with ropivacaine, Ropivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PECS block with ropivacaineProcedure or surgery
Also called Pectoral muscles sheath block
Local anesthetic (ropivacaine 0.5%, total volume 30 ml) is infiltrated in between the fasciae of serratus and minor pectoralis muscles under ultrasound guidance.
Paravertebral block with ropivacaineProcedure or surgery
Also called PVB
Local anesthetic (ropivacaine 0.5%, total volume 20 ml) is infiltrated in the paravertebral block at T4 level under ultrasound guidance.
RopivacaineDrug
Also called Naropine
Amidic local anesthetic standardly used for nerve block and infiltration
| Study group | Role | What they receive |
|---|---|---|
| Paravertebral block with ropivacaine | Active comparator | Patients are treated with an older technique (paravertebral block with ropivacaine), somehow established in treating pain after breast surgery. This technique has been shown to be effective but has an intrinsic risk of iatrogenic pneumothorax and is considered technically demanding. Receives: Procedure: Paravertebral block with ropivacaine; Drug: Ropivacaine |
| PECS block with ropivacaine | Experimental | Patients are treated with PECS block, which has been already adopted in common clinical practice as an alternative to paravertebral block for postoperative pain treatment after breast surgery. This technique is thought to be somehow simpler to perform and safer with regard to pneumothorax, however no studies have been done yet to statistically compare the two blocks with regard to safety and effectiveness. Receives: Procedure: PECS block with ropivacaine; Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate (measured via visual analogue scale)
Changes in postoperative pain level of intensity over time will be measured via visual analogue scale (on a 0 to 100 scale, where 0 means no pain and 100 stands for the maximum pain ever experienced). Patients in both groups will be asked to rate their postoperative pain levels at fixed intervals, i.e. in the postoperative anesthesia care unit and once in the ward at 6, 12, 24 hours after surgery
Measured: 24 hours after surgery
Secondary outcomes (2)
Safety (incidence of complications)
Safety will be assessed as incidence of complications in the two groups over the first 24hours. Complications monitored will be: clinical signs of pneumothorax, inadvertent vascular puncture, local anesthetic toxicity
Measured: 24 hours after surgery
Patients' satisfaction (subjective perception of the experience on a 0 to 100 scale)
Patients will be asked to rate their satisfaction with regard to procedural pain and subjective perception of the experience on a 0 to 100 scale
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2016 (estimated)
- Study start1 Jan 2018
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
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 Other Acute Postoperative PainStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Regionale Bellinzona e Valli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Saporito, Ospedale Regionale Bellinzona e Valli
- Investigators
- Luciano Anselmi, MD, Study chair, Ospedale Regionale Bellinzona e Valli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02645474
- Sponsor's protocol ID
- PECS
- Status last verified
- Aug 2024
- First submitted
- 29 Dec 2015
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dossi R, Tasciotti E, van Sander K, Maino P, Reyes Lozano V, Saporito A, Koetsier E. Comparison of Pectoral Nerve and Paravertebral Blocks for Postoperative Pain Management in Breast Surgery: A Multicentre Randomised Double-Blind Trial. J Breast Cancer. 2025 Aug;28(4):268-279. doi: 10.4048/jbc.2025.0060.
PubMed 40887728
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is PECS Block Equivalent to Paravertebral Block in Preventing Postoperative Pain After Breast Surgery? A Randomized, Controlled, Double-blind, Multicenter Trial
- ClinicalTrials.gov ID
- NCT02645474
- Acronym / sponsor ID
- PECS
- Conditions
- Other Acute Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Ospedale Regionale Bellinzona e ValliUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 1 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.
Two regional anesthesia techniques already in use in common clinical practice -paravertebral block and pectoral nerve block (PECS block) are compared in a randomized, double-blind, multicenter, controlled, non-inferiority trial, in order to compare their success rate in patients udergoing breast surgery.
Detailed description
Aim of the study is to compare paravertebral block and PECS block success rate in patients undergoing elective breast surgery (mastectomy or quadrantectomy) with a combined anesthesia technique.
Primary outcome is block success rate defined as a VAS score of 30 or less in PACU and at 6, 12 and 24 hours after surgery. Secondary outcomes are: rescue opioids requirement; incidence of procedure related complications; incidence of postoperative side-effects; patients' quality of life level during the first 24 postoperative hours; patients' satisfaction.
A prospective, randomized, controlled, double-blinded, non-inferiority trial was designed in order to compare paravertebral block and PECS block with regard to block success over the first 24 hours postoperatively in patients undergoing mastectomy or quadrantectomy procedures with a combined anesthesia technique.
Inclusion criteria: adult patients, ASA class 1 to 3, scheduled for elective mastectomy or quadrantectomy. Exclusion criteria: patients refusal, contraindication to regional anaesthesia (coagulopathies, concurrent anticoagulant therapy, allergy to local anaesthetics, infection at puncture site).
After written informed consent, patients will be randomized into two cohorts, the first being treated with a paravertebral block, while the second with a PECS block. Both procedures will be standardized with regard to injection technique, local anaesthetic drug and volume and performed under ultrasound real-time guidance. Both groups will undergo the regional anesthesia technique after induction of general anaesthesia to be blinded with regard to the type of block. This will be standardized as well, according to our centers current clinical practice. Postoperative pain will be than measured on a validated visual analogue scale (VAS 0-100) in the recovery room and periodically after discharge to the ward until 24 hours postoperatively. Rescue opioids requirement will be recorded. Eventual procedural complications occurred will be recorded as well as postoperative side effects. A questionnaire about patients' satisfaction and quality of life during the first 24 postoperative hours will be filled in for every patient. Data collected will be initially inserted in a form and subsequently collected, pooled and anonymously registered in an electronic data base.
A sample size calculation has been preliminary performed with regard to the primary outcome. A 20% difference in the blocks success rate (defined as a postoperative pain on VAS scale of 30 or less) will be considered as clinically significant.
In our practice, paravertebral block is the current gold standard and it is associated on average to a 50% mean value on VAS scale during the first 48 postoperative hours. PECS block will be thus compared to this standard of care. A total of 39 patients per arm will be required (95% confidence interval). Accounting for a 10% drop-out rate, we will include 43 patients per arm.
Pain levels will be measured as medians and interquartile ranges. Statistical analysis will be performed using Student t-test for normally distributed variables while Mann-Whitney test was applied to non-normally distributed variables.
This study will be conducted in compliance with the protocol, the current version of the Declaration of Helsinki, the ICH-GCP or ISO EN 14155 (as far as applicable) as well as all national legal and regulatory requirements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paravertebral block with ropivacaine | Active comparator | Procedure: Paravertebral block with ropivacaine, Drug: RopivacainePatients are treated with an older technique (paravertebral block with ropivacaine), somehow established in treating pain after breast surgery. This technique has been shown to be effective but has an intrinsic risk of iatrogenic pneumothorax and is considered technically demanding. |
| PECS block with ropivacaine | Experimental | Procedure: PECS block with ropivacaine, Drug: RopivacainePatients are treated with PECS block, which has been already adopted in common clinical practice as an alternative to paravertebral block for postoperative pain treatment after breast surgery. This technique is thought to be somehow simpler to perform and safer with regard to pneumothorax, however no studies have been done yet to statistically compare the two blocks with regard to safety and effectiveness. |
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)
- adult patients
- ASA class 1 to 3 patients
- patients scheduled for elective breast mastectomy or quadrantectomy
Key exclusion criteria (2 listed)
- patients' refusal
- contraindication to regional anaesthesia (coagulopathies, concurrent anticoagulant therapy, allergy to local anaesthetics, infection at puncture site)
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 block with ropivacaineAlso: Pectoral muscles sheath blockLocal anesthetic (ropivacaine 0.5%, total volume 30 ml) is infiltrated in between the fasciae of serratus and minor pectoralis muscles under ultrasound guidance. | Procedure or surgery | PECS block with ropivacaine |
| Paravertebral block with ropivacaineAlso: PVBLocal anesthetic (ropivacaine 0.5%, total volume 20 ml) is infiltrated in the paravertebral block at T4 level under ultrasound guidance. | Procedure or surgery | Paravertebral block with ropivacaine |
| RopivacaineAlso: NaropineAmidic local anesthetic standardly used for nerve block and infiltration | Drug | PECS block with ropivacaine, Paravertebral block with ropivacaine |
Primary outcome
Success rate (measured via visual analogue scale)
Time frame: 24 hours after surgery
Changes in postoperative pain level of intensity over time will be measured via visual analogue scale (on a 0 to 100 scale, where 0 means no pain and 100 stands for the maximum pain ever experienced). Patients in both groups will be asked to rate their postoperative pain levels at fixed intervals, i.e. in the postoperative anesthesia care unit and once in the ward at 6, 12, 24 hours after surgery
2 secondary outcomes
Safety (incidence of complications)
Time frame: 24 hours after surgery
Patients' satisfaction (subjective perception of the experience on a 0 to 100 scale)
Time frame: 24 hours after 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 6 Aug 2024.
- Derived from this study: PubMed 40887728Dossi R, Tasciotti E, van Sander K, Maino P, Reyes Lozano V, Saporito A, Koetsier E. Comparison of Pectoral Nerve and Paravertebral Blocks for Postoperative Pain Management in Breast Surgery: A Multicentre Randomised Double-Blind Trial. J Breast Cancer. 2025 Aug;28(4):268-279. doi: 10.4048/jbc.2025.0060.
- 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.
Luciano Anselmi, MD study chair
Ospedale Regionale Bellinzona e Valli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PECS block with ropivacaine, Paravertebral block with ropivacaine and Ropivacaine in people with Other Acute Postoperative Pain, run by Ospedale Regionale Bellinzona e Valli at 1 site in Switzerland.
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 2 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 6 Aug 2024. 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 Switzerland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Success rate (measured via visual analogue scale) (time frame: 24 hours after surgery). 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 NCT02645474, 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 6 Aug 2024.