Mastectomy; LymphedemaPhase 4SAPLIANCT04756791
Prospective Comparison of Single-Injection Serratus Anterior Plane Block With Ropivacaine Versus Local Infiltration of Anaesthetic After Breast Surgery
A Phase 4 study testing SAPB and Local Injection Anesthesia in people with Mastectomy; Lymphedema, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
To evaluate whether a serratus anterior plane block (SAPB) is more effective than a local infiltration anesthesia (LIA) with an equal dose and same anesthetic performed by the surgeon, as an adjuvant to treat postoperative pain after unilateral mastectomy. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Mastectomy; Lymphedema
- What is being tested?
- SAPB and Local Injection Anesthesia
- 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 siteBelgium
- Study dates
- 16 Jun 2021to 31 Dec 2024
- 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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years.
- Provision of signed informed consent prior to any study-specific procedure.
- Patients who come to preoperative anesthesia consultation for their scheduled unilat-eral mastectomy.
Who cannot join
- Age >80 years
- History of chronic pain or drug treatment abuse
- Depression, psychiatric morbidity or mal-adaptive coping behavior
- Neuropathy
- Severe anxiety or other mental ailment, taking drugs affecting their capacity to assess pain
- Chronic or acute skin infection of the lateral thorax
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- Hypersensitivity to ropivacaine
- Severe hepatic or renal disease
- Refuse to participate to the study
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate whether a serratus anterior plane block (SAPB) is more effective than a local infiltration anesthesia (LIA) with an equal dose and same anesthetic performed by the surgeon, as an adjuvant to treat postoperative pain after unilateral mastectomy.
Read the detailed description
To evaluate whether a serratus anterior plane block (SAPB) is more effective than a local infiltration anesthesia (LIA) with an equal dose and same anesthetic performed by the surgeon, as an adjuvant to treat postoperative pain after unilateral mastectomy.
Primary endpoint: the use of opioid's in the postoperative period. Secondary endpoint: Numerical Pain Rating Scale (NPRS) score recorded at the 2nd, 8th, 16th, 24th hour after surgery. 0 means no pain and 10 is the worst pain imaginable. In addition at the same time, we will look to the degree of arm mobilization where there will be 3 possible groups: 1. restricted, 2. fair mobilization and 3. free mobilization.
There are 2 treatment arms: 1st arm is the standard therapy, namely the local infiltration anesthesia. 2nd arm is the experimental arm, namely the SAPB. Patients are randomised into each arm after screening.
- Conditions
- Mastectomy; Lymphedema
- Being tested
- SAPB, Local Injection Anesthesia
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAPBProcedure or surgery
local anesthetic is injected between the serratus anterior and latissimus dorsi muscles.
Local Injection AnesthesiaProcedure or surgery
Anesthesia is injected directly into the tissue that is will be numbing.
| Study group | Role | What they receive |
|---|---|---|
| Local infiltration anesthesia | Active comparator | Patients will receive local infiltration anesthesia with ropivacaine placed by surgeon. Receives: Procedure: Local Injection Anesthesia |
| Serratus anterior plane block | Experimental | Patients receive a SAPB with ropivacaine placed by anesthesiologist. Receives: Procedure: SAPB |
What is being measured
The primary outcome is the main question the study is designed to answer.
The use of opioids in the postoperative period
Patients receive a patient controlled intravenous anesthesia pump with morphine. We will be able to analyze the total amount of opioid requested by the patient.
Measured: 24 hours
Secondary outcomes (2)
Numerical Pain Rating Scale
Patients will be asked at 4 different time points the amount of pain they are feeling on a scale of 0 to 10. 0 meaning no pain and 10 meaning the worst pain imaginable.
Measured: 24 hours
Degree of arm mobilization
How much can the arm be mobilized of the patients? 3 groups: 1: restricted, 2: fair mobilization and 3. free mobilization
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start16 Jun 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2024
Why it stopped: no participants recruited due to logistic problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mastectomy; LymphedemaStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04756791
- Sponsor's protocol ID
- SAPLIA
- Acronym
- SAPLIA
- Status last verified
- May 2023
- First submitted
- 11 Feb 2021
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparison of Single-Injection Serratus Anterior Plane Block With Ropivacaine Versus Local Infiltration of Anaesthetic After Breast Surgery
- ClinicalTrials.gov ID
- NCT04756791
- Acronym / sponsor ID
- SAPLIA / SAPLIA
- Conditions
- Mastectomy; Lymphedema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no participants recruited due to logistic problems
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 16 Feb 2021 (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.
To evaluate whether a serratus anterior plane block (SAPB) is more effective than a local infiltration anesthesia (LIA) with an equal dose and same anesthetic performed by the surgeon, as an adjuvant to treat postoperative pain after unilateral mastectomy.
Detailed description
To evaluate whether a serratus anterior plane block (SAPB) is more effective than a local infiltration anesthesia (LIA) with an equal dose and same anesthetic performed by the surgeon, as an adjuvant to treat postoperative pain after unilateral mastectomy.
Primary endpoint: the use of opioid's in the postoperative period. Secondary endpoint: Numerical Pain Rating Scale (NPRS) score recorded at the 2nd, 8th, 16th, 24th hour after surgery. 0 means no pain and 10 is the worst pain imaginable. In addition at the same time, we will look to the degree of arm mobilization where there will be 3 possible groups: 1. restricted, 2. fair mobilization and 3. free mobilization.
There are 2 treatment arms: 1st arm is the standard therapy, namely the local infiltration anesthesia. 2nd arm is the experimental arm, namely the SAPB. Patients are randomised into each arm after screening.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local infiltration anesthesia | Active comparator | Procedure: Local Injection AnesthesiaPatients will receive local infiltration anesthesia with ropivacaine placed by surgeon. |
| Serratus anterior plane block | Experimental | Procedure: SAPBPatients receive a SAPB with ropivacaine placed by anesthesiologist. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-80 years.
- Provision of signed informed consent prior to any study-specific procedure.
- Patients who come to preoperative anesthesia consultation for their scheduled unilat-eral mastectomy.
Key exclusion criteria (10 listed)
- Age >80 years
- History of chronic pain or drug treatment abuse
- Depression, psychiatric morbidity or mal-adaptive coping behavior
- Neuropathy
- Severe anxiety or other mental ailment, taking drugs affecting their capacity to assess pain
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 |
|---|---|---|
| SAPBlocal anesthetic is injected between the serratus anterior and latissimus dorsi muscles. | Procedure or surgery | Serratus anterior plane block |
| Local Injection AnesthesiaAnesthesia is injected directly into the tissue that is will be numbing. | Procedure or surgery | Local infiltration anesthesia |
Primary outcome
The use of opioids in the postoperative period
Time frame: 24 hours
Patients receive a patient controlled intravenous anesthesia pump with morphine. We will be able to analyze the total amount of opioid requested by the patient.
2 secondary outcomes
Numerical Pain Rating Scale
Time frame: 24 hours
Degree of arm mobilization
Time frame: 24 hours
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 18 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 SAPB and Local Injection Anesthesia in people with Mastectomy; Lymphedema, run by Universitair Ziekenhuis Brussel 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 3 inclusion and 10 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 18 Dec 2025. 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. 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 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?
The use of opioids in the postoperative period (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 18 Dec 2025.