Prospective Comparison of Single-Injection Serratus Anterior Plane Block With Ropivacaine Versus Local Infiltration of Anaesthetic After Breast Surgery
NCT ID: NCT04756791
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2021-06-16
2024-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Local infiltration anesthesia
Patients will receive local infiltration anesthesia with ropivacaine placed by surgeon.
Local Injection Anesthesia
Anesthesia is injected directly into the tissue that is will be numbing.
Serratus anterior plane block
Patients receive a SAPB with ropivacaine placed by anesthesiologist.
SAPB
local anesthetic is injected between the serratus anterior and latissimus dorsi muscles.
Interventions
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SAPB
local anesthetic is injected between the serratus anterior and latissimus dorsi muscles.
Local Injection Anesthesia
Anesthesia is injected directly into the tissue that is will be numbing.
Eligibility Criteria
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Inclusion Criteria
* Provision of signed informed consent prior to any study-specific procedure.
* Patients who come to preoperative anesthesia consultation for their scheduled unilat-eral mastectomy.
Exclusion Criteria
* 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
* Hypersensitivity to ropivacaine
* Severe hepatic or renal disease
* Refuse to participate to the study
* Pregnancy
18 Years
80 Years
FEMALE
No
Sponsors
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Universitair Ziekenhuis Brussel
OTHER
Responsible Party
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Locations
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UZ Brussel
Jette, Brussels Capital, Belgium
Countries
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Other Identifiers
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SAPLIA
Identifier Type: -
Identifier Source: org_study_id