Erector Spina Plane Block vs Serratus Anterior Plane Block for Postoperative Mastectomy Pain
Comparison of Erector Spina Plane Block and Serratus Anterior Plane Block in Patients Undergoing Mastectomy
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
The aim of this study is to compare the efficiency of serratus anterior plane block and erector spina plane block on analgesic consumption, postoperative pain and patient's satisfaction and recovery quality in patients undergoing mastectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2020
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
March 3, 2020
CompletedFirst Posted
Study publicly available on registry
March 5, 2020
CompletedStudy Start
First participant enrolled
March 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 27, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2021
CompletedMarch 12, 2020
March 1, 2020
12 months
March 3, 2020
March 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Analgesic consumption
Tramadol dose will be calculated as milligram
From at the end of surgery (at postoperative 0th hour) to postoperative 24th hours
Secondary Outcomes (3)
Postoperative pain intensity
At 0,2,4,6,12,24th hours after surgery
Quality of recovery
At postoperative 24th hours
The number of patients with perioperative side effects
From 30 minute before surgery to postoperative 24th hours
Study Arms (2)
serratus anterior plane block
ACTIVE COMPARATORThe serratus anterior plane block will be performed under ultrasound guidance in the preoperative term. Tramadol will be administered via patient controlled analgesia (PCA) device at 20 mg bolus dose with 10 min. lockout time without basal infusion dose.
erector spina plane block
ACTIVE COMPARATORThe erector spina plane block will be performed under ultrasound guidance in the preoperative term. Tramadol will be administered via PCA device at 20 mg bolus dose with 10 min. lockout time without basal infusion dose.
Interventions
ultrasound guided serratus anterior plane block will be done with % 0.25 bupivacaine.
ultrasound guided erector spina plane block will be done with % 0.25 bupivacaine.
Eligibility Criteria
You may qualify if:
- American society of score anesthesiologist I-II-III
- Elective modified radical mastectomy
- years old
You may not qualify if:
- neurological disease
- coagulopathy disease or using anticoagulants
- non-cooperative
- allergic to one of the drugs used in the study
- recurrent breast cancer
- body mass index is above 35
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- asist.prof.
Study Record Dates
First Submitted
March 3, 2020
First Posted
March 5, 2020
Study Start
March 18, 2020
Primary Completion
February 27, 2021
Study Completion
March 15, 2021
Last Updated
March 12, 2020
Record last verified: 2020-03