- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06269562
SPSIPB and CPB on Clavicle Surgeries
February 13, 2024 updated by: Fatih Balci, Cumhuriyet University
Postoperative Analgesic Efficacy of Clavipectoral Plan Block and Serratus Posterior Superior Intercostal Plane Block Combination in Clavicle Surgeries: A Report of Five Cases
Clavicular fractures represent a common occurrence often necessitating effective pain management strategies, particularly following surgical interventions.
This study involved a cohort of five patients who underwent clavicular fracture surgery under general anesthesia.
A novel analgesic approach combining two distinct nerve block techniques-Serratus Posterior Superior Intercostal Plane Block (SPSIPB) and Clavipectoral Plane Block (CPB)-was employed for postoperative pain control.
The procedural methodology encompassed the administration of SPSIPB preceding anesthesia induction, followed by CPB subsequent to induction.
SPSIPB targeted specific neural regions responsible for sensory blockade within the innervation of the clavicular skin, whereas CPB focused on the clavipectoral fascia.
Standard anesthesia protocols were utilized, and postoperative pain levels were evaluated using Numeric Rating Scores (NRS).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Sivas, Turkey, 58050
- Sivas Cumhuriyet University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Five American Society of Anesthesiologists (ASA) Ⅰ-II- III patients scheduled for clavicle surgery will be included in the study
Exclusion Criteria:
- patients with bleeding disorders
- patients with signs of infection in the block application area
- patients with unstable haemodynamics
- patients with thyroid cardiovascular, renal, hepatic and neuropsychiatric diseases
- patients with vascular disease,
- patients with respiratory distress
- patients whose consent for the study could not be obtained or who did not accept to participate in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Block
consists of 5 patients in whom both techniques were applied
|
The analgesic effectiveness achieved by the concurrent application of these two techniques was investigated.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numerical Rating Scale
Time Frame: 24 hours after the procedure
|
0=no pain , 10= the worst pain
|
24 hours after the procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
tramadol consumption
Time Frame: 24 hours after the procedure
|
total tramadol consumption of patients
|
24 hours after the procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 20, 2023
Primary Completion (Actual)
December 20, 2023
Study Completion (Actual)
February 4, 2024
Study Registration Dates
First Submitted
February 6, 2024
First Submitted That Met QC Criteria
February 13, 2024
First Posted (Estimated)
February 21, 2024
Study Record Updates
Last Update Posted (Estimated)
February 21, 2024
Last Update Submitted That Met QC Criteria
February 13, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- clavicle
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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