Study Stopped
no participants recruited due to logistic problems
Prospective Comparison of Single-Injection Serratus Anterior Plane Block With Ropivacaine Versus Local Infiltration of Anaesthetic After Breast Surgery
SAPLIA
1 other identifier
interventional
N/A
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2021
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2021
CompletedFirst Posted
Study publicly available on registry
February 16, 2021
CompletedStudy Start
First participant enrolled
June 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedDecember 18, 2025
May 1, 2023
2.5 years
February 11, 2021
December 11, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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.
24 hours
Secondary Outcomes (2)
Numerical Pain Rating Scale
24 hours
Degree of arm mobilization
24 hours
Study Arms (2)
Local infiltration anesthesia
ACTIVE COMPARATORPatients will receive local infiltration anesthesia with ropivacaine placed by surgeon.
Serratus anterior plane block
EXPERIMENTALPatients receive a SAPB with ropivacaine placed by anesthesiologist.
Interventions
local anesthetic is injected between the serratus anterior and latissimus dorsi muscles.
Anesthesia is injected directly into the tissue that is will be numbing.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- Hypersensitivity to ropivacaine
- Severe hepatic or renal disease
- Refuse to participate to the study
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UZ Brussel
Jette, Brussels Capital, 1090, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2021
First Posted
February 16, 2021
Study Start
June 16, 2021
Primary Completion
December 31, 2023
Study Completion
December 31, 2024
Last Updated
December 18, 2025
Record last verified: 2023-05