Back to resultsAnalgesic Efficacy of Serratus Anterior Plane Block in The Rib Fractures Pain
Primary Purpose
Serratus Plane Block
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Serratus Plane Block
Control
Sponsored by
About this trial
This is an interventional treatment trial for Serratus Plane Block
Eligibility Criteria
Inclusion Criteria:
Rib fracture pain and had a Numerical Rating Scale (NRS) score of ≥ 4 ASA I-II-III
Exclusion Criteria:
Patients with infection at the injection site Coagulopathy Allergy to amide-type local anesthetics History of peripheral neuropathy Hepatic and/or renal failure Refusing the procedure
Sites / Locations
- Kahramanmaras Sutcu Imam University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Serratus Plane Block
Control
Arm Description
The Serratus plane block was performed, tramadol was administered with patient-controlled analgesia (PCA) and all patients were followed in the ward.
No block was performed, tramadol was administered with patient-controlled analgesia (PCA) and all patients were followed in the ward.
Outcomes
Primary Outcome Measures
Analgesic consumption
Tramadol
Secondary Outcome Measures
Numerical Rating Scale (NRS)
pain scores
Full Information
NCT ID
NCT04293354
First Posted
February 29, 2020
Last Updated
February 29, 2020
Sponsor
Kahramanmaras Sutcu Imam University
1. Study Identification
Unique Protocol Identification Number
NCT04293354
Brief Title
Analgesic Efficacy of Serratus Anterior Plane Block in The Rib Fractures Pain
Official Title
Analgesic Efficacy of Serratus Anterior Plane Block in The Rib Fractures Pain
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
April 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kahramanmaras Sutcu Imam University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Serratus Anterior Plane Block (SAPB) is a facial plane block that was first described by Blanco in 2013 and that blocks the lateral cutaneous branches of the T2-T9 intercostal nerves, the intercostobrachial nerve, n. thoracic longus, n. thoracodorsalis nerves. Case and case series have been reported in the literature on the use of SAPB in rib fractures, and it has been reported as an effective analgesia method. We apply SAPB to patients with rib fractures with pain in our clinic.
Our aim is to evaluate SAPB for patients with rib fractures pain and to compare them with the control group in terms of total analgesic consumption and pain scores.
Detailed Description
After Ethics Committee approval patients with rib fracture pain and have a Numerical Rating Scale (NRS) score of ≥ 4, included the study. The patients were randomized by the closed envelope method. The patients were divided into two groups as the SAPB-performed group (Group S) and the Control group (Group K). Intravenous patient-controlled analgesia (PCA) device prepared with tramadol was applied to all patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Serratus Plane Block
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Serratus Plane Block
Arm Type
Active Comparator
Arm Description
The Serratus plane block was performed, tramadol was administered with patient-controlled analgesia (PCA) and all patients were followed in the ward.
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
No block was performed, tramadol was administered with patient-controlled analgesia (PCA) and all patients were followed in the ward.
Intervention Type
Procedure
Intervention Name(s)
Serratus Plane Block
Intervention Description
Serratus Plane Block was performed
Intervention Type
Procedure
Intervention Name(s)
Control
Intervention Description
No block was performed
Primary Outcome Measure Information:
Title
Analgesic consumption
Description
Tramadol
Time Frame
up to 24 hour
Secondary Outcome Measure Information:
Title
Numerical Rating Scale (NRS)
Description
pain scores
Time Frame
at 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Rib fracture pain and had a Numerical Rating Scale (NRS) score of ≥ 4 ASA I-II-III
Exclusion Criteria:
Patients with infection at the injection site Coagulopathy Allergy to amide-type local anesthetics History of peripheral neuropathy Hepatic and/or renal failure Refusing the procedure
Facility Information:
Facility Name
Kahramanmaras Sutcu Imam University Hospital
City
Kahramanmaras
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28447227
Citation
Okmen K, Okmen BM. The efficacy of serratus anterior plane block in analgesia for thoracotomy: a retrospective study. J Anesth. 2017 Aug;31(4):579-585. doi: 10.1007/s00540-017-2364-9. Epub 2017 Apr 26.
Results Reference
background
PubMed Identifier
33383266
Citation
Teksen S, Oksuz G, Oksuz H, Sayan M, Arslan M, Urfalioglu A, Gisi G, Bilal B. Analgesic efficacy of the serratus anterior plane block in rib fractures pain: A randomized controlled trial. Am J Emerg Med. 2021 Mar;41:16-20. doi: 10.1016/j.ajem.2020.12.041. Epub 2020 Dec 23.
Results Reference
derived
Learn more about this trial
Analgesic Efficacy of Serratus Anterior Plane Block in The Rib Fractures Pain
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