Back to resultsSuperficial Serratus Plane Block for Modified Radical Mastectomy and Axillary Lymph Node Disection
Primary Purpose
Postoperative Analgesia, Pain, Postoperative, Opioid Consumption
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bupivacaine
Saline
Ultrasound
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Analgesia focused on measuring Superficial Serratus Plane Block, Modified Radical Mastectomy, Axillary Lymph Node Disection, bupivacaine
Eligibility Criteria
Inclusion Criteria:
- American Society of Anesthesiologist's physiologic state I-III patients undergoing Modified Radical Mastectomy and Axillary Lymph Node Disection
Exclusion Criteria:
- chronic pain, bleeding disorders, renal or hepatic insufficiency,patients on chronic non-steroidal anti-inflammatory medications
Sites / Locations
- Regional Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group SPB
Group Control
Arm Description
Ultrasound guided serratus plane block with 30 ml %0,25 bupivacaine
Ultrasound guided sham block with 2 ml saline subcutaneously
Outcomes
Primary Outcome Measures
Opioid Consumption
First 24 hours total fentanyl consumption with patient controlled analgesia
Secondary Outcome Measures
Visual analog pain score
Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at first hour postoperatively.
Visual analog pain score
Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at second hour postoperatively.
Visual analog pain score
Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 4th hour postoperatively.
Visual analog pain score
Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 8th hour postoperatively.
Visual analog pain score
Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 12th hour postoperatively.
Visual analog pain score
Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 24th hour postoperatively.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03341234
Brief Title
Superficial Serratus Plane Block for Modified Radical Mastectomy and Axillary Lymph Node Disection
Official Title
Analgesic Efficiency of Superficial Serratus Plane Block for Modified Radical Mastectomy and Axillary Lymph Node Disection: Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
November 1, 2016 (Actual)
Primary Completion Date
March 1, 2017 (Actual)
Study Completion Date
August 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Breast cancer is the most common type of cancer in women. Mastectomy and axillary lymph node disection are commonly performed as part of the cancer management. This surgery can cause significant postoperative pain. The serratus plane block (SPB) has been described for analgesia of the hemithorax and reported for many cases such as thoracoscopy, shoulder arthroscopy, breast surgery and axillary lymph node dissections. Serratus plane block may be a viable alternative to current regional anaesthetic techniques such as thoracic paravertebral and central neuraxial blockade.
The aim of this study is to determine effectiveness of ultrasound guided superficial serratus plane block in patients undergoing modified radical mastectomy and axillary lymph node dissection surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Analgesia, Pain, Postoperative, Opioid Consumption
Keywords
Superficial Serratus Plane Block, Modified Radical Mastectomy, Axillary Lymph Node Disection, bupivacaine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group SPB
Arm Type
Active Comparator
Arm Description
Ultrasound guided serratus plane block with 30 ml %0,25 bupivacaine
Arm Title
Group Control
Arm Type
Active Comparator
Arm Description
Ultrasound guided sham block with 2 ml saline subcutaneously
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
30 ml %0,25 bupivacaine
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
2 ml saline subcutaneously
Intervention Type
Device
Intervention Name(s)
Ultrasound
Intervention Description
Ultrasound guided block
Primary Outcome Measure Information:
Title
Opioid Consumption
Description
First 24 hours total fentanyl consumption with patient controlled analgesia
Time Frame
First 24 hours total opioid consumption
Secondary Outcome Measure Information:
Title
Visual analog pain score
Description
Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at first hour postoperatively.
Time Frame
postoperative first hour
Title
Visual analog pain score
Description
Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at second hour postoperatively.
Time Frame
postoperative second hour
Title
Visual analog pain score
Description
Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 4th hour postoperatively.
Time Frame
postoperative 4th hour
Title
Visual analog pain score
Description
Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 8th hour postoperatively.
Time Frame
postoperative 8th hour
Title
Visual analog pain score
Description
Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 12th hour postoperatively.
Time Frame
postoperative 12th hour
Title
Visual analog pain score
Description
Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 24th hour postoperatively.
Time Frame
postoperative 24th hour
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 Anesthesiologist's physiologic state I-III patients undergoing Modified Radical Mastectomy and Axillary Lymph Node Disection
Exclusion Criteria:
chronic pain, bleeding disorders, renal or hepatic insufficiency,patients on chronic non-steroidal anti-inflammatory medications
Facility Information:
Facility Name
Regional Training and Research Hospital
City
Erzurum
ZIP/Postal Code
25070
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23923989
Citation
Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7.
Results Reference
background
PubMed Identifier
28336228
Citation
Ahiskalioglu A, Alici HA, Yayik AM, Celik M, Oral Ahiskalioglu E. Ultrasound guided serratus plane block for management of acute thoracic herpes zoster. Anaesth Crit Care Pain Med. 2017 Oct;36(5):323-324. doi: 10.1016/j.accpm.2017.01.008. Epub 2017 Mar 21. No abstract available.
Results Reference
background
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Superficial Serratus Plane Block for Modified Radical Mastectomy and Axillary Lymph Node Disection
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