Erector Spina Plane Block vs Serratus Anterior Plane Block for Postoperative Mastectomy Pain
Primary Purpose
Mastectomy, Pain, Postoperative, Recovery Period, Anesthesia
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
serratus anterior plane block
erector spina plane block
Sponsored by
About this trial
This is an interventional treatment trial for Mastectomy focused on measuring Pain Management, Quality of Healthcare
Eligibility Criteria
Inclusion Criteria:
- American society of score anesthesiologist I-II-III
- Elective modified radical mastectomy
- 18-65 years old
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
serratus anterior plane block
erector spina plane block
Arm Description
The 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.
The 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.
Outcomes
Primary Outcome Measures
Analgesic consumption
Tramadol dose will be calculated as milligram
Secondary Outcome Measures
Postoperative pain intensity
Numeric rating scale which is 0 to 10 will be recorded.In this scale, 0 is no pain, 10 is the worst pain.
Quality of recovery
Quality of recovery (QoR-40) questionaire will be recorded. The QoR-40 is a questionaire which measures of five dimensions of health: patient support, comfort, emotions, physical independence, and pain on a five-point likert scale. QoR-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery)
The number of patients with perioperative side effects
The number of patients with perioperative side effects(emesis, nausea, local anesthetic toxicity, pneumothorax, local hematoma) will be recorded
Full Information
NCT ID
NCT04296188
First Posted
March 3, 2020
Last Updated
March 11, 2020
Sponsor
Tokat Gaziosmanpasa University
1. Study Identification
Unique Protocol Identification Number
NCT04296188
Brief Title
Erector Spina Plane Block vs Serratus Anterior Plane Block for Postoperative Mastectomy Pain
Official Title
Comparison of Erector Spina Plane Block and Serratus Anterior Plane Block in Patients Undergoing Mastectomy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 18, 2020 (Anticipated)
Primary Completion Date
February 27, 2021 (Anticipated)
Study Completion Date
March 15, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tokat Gaziosmanpasa University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Mastectomy may cause severe postoperative pain. There are several analgesic methods for postoperative pain management. Serratus anterior plane (SAP) block is an interfascial plane block which is performed into the fascial plane of serratus anterior muscle. It provides effective analgesia in anterior, posterior and lateral dermatomes of thorax. There are several studies about its analgesic efficacy for mastectomy pain. The erector spina plane (ESP) block is another novel plan block which provides analgesia at multi-dermatomal area of the anterior, posterior, and lateral thoracic and abdominal walls. There are some studies about its effectiveness for postoperative mastectomy pain management. However, according to our best knowledge, there is no literature comparing the efficacy of ESP block and SAP block patients undergoing mastectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mastectomy, Pain, Postoperative, Recovery Period, Anesthesia
Keywords
Pain Management, Quality of Healthcare
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
serratus anterior plane block
Arm Type
Active Comparator
Arm Description
The 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.
Arm Title
erector spina plane block
Arm Type
Active Comparator
Arm Description
The 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.
Intervention Type
Procedure
Intervention Name(s)
serratus anterior plane block
Intervention Description
ultrasound guided serratus anterior plane block will be done with % 0.25 bupivacaine.
Intervention Type
Procedure
Intervention Name(s)
erector spina plane block
Intervention Description
ultrasound guided erector spina plane block will be done with % 0.25 bupivacaine.
Primary Outcome Measure Information:
Title
Analgesic consumption
Description
Tramadol dose will be calculated as milligram
Time Frame
From at the end of surgery (at postoperative 0th hour) to postoperative 24th hours
Secondary Outcome Measure Information:
Title
Postoperative pain intensity
Description
Numeric rating scale which is 0 to 10 will be recorded.In this scale, 0 is no pain, 10 is the worst pain.
Time Frame
At 0,2,4,6,12,24th hours after surgery
Title
Quality of recovery
Description
Quality of recovery (QoR-40) questionaire will be recorded. The QoR-40 is a questionaire which measures of five dimensions of health: patient support, comfort, emotions, physical independence, and pain on a five-point likert scale. QoR-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery)
Time Frame
At postoperative 24th hours
Title
The number of patients with perioperative side effects
Description
The number of patients with perioperative side effects(emesis, nausea, local anesthetic toxicity, pneumothorax, local hematoma) will be recorded
Time Frame
From 30 minute before surgery to postoperative 24th hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
American society of score anesthesiologist I-II-III
Elective modified radical mastectomy
18-65 years old
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mehtap gürler balta, MD
Phone
+903562129500
Ext
3494
Email
drmehtapgurler@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
tuğba karaman, MD
Phone
+903562129500
Ext
3498
Email
drtugbaguler@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Erector Spina Plane Block vs Serratus Anterior Plane Block for Postoperative Mastectomy Pain
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