- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05911373
Serratus Plane Block Versus Serratus Plane Block Plus Parasternal Block Combination for Breast Surgery
March 29, 2024 updated by: Ali Ahiskalioglu, Ataturk University
Serratus Plane Block Versus Serratus Plane Block Plus Parasternal Block on Postoperative Opioid Consumption and Dermatomal Analyses for Breast Surgery
Mastectomy is a technique often used in breast cancer surgery.
Patients experience moderate to severe pain postoperatively after this procedure.
Various plane blocks, NSAIDs, and opioid analgesics can be administered to these patients as components of multimodal analgesia.
In the the study, the investigators aimed to evaluate the analgesic effects of the serratus plane block, the parasternal block added to the serratus plane block, and the dermatomal differences.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
64
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 Contact
- Name: Ali Ahiskalioglu
- Phone Number: +905444424831
- Email: aliahiskalioglu@hotmail.com
Study Locations
-
-
-
Erzurum, Turkey, 25100
- Ali Ahiskalioglu
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- American Society of Anesthesiologist's physiologic state I-III patients
- To undergo Mastectomy Surgery
- Being between the ages of 18-65 years
Exclusion Criteria:
- Having a known heart, kidney, liver or hematological disease
- Having a history of peptic ulcer, gastrointestinal bleeding, allergy, chronic pain
- Routine analgesic use and history of analgesic use in the last 24 hours
- Not willing to participate in the study
- Uncooperative patients who have coagulopathy or use anticoagulant drugs
- To be allergic to one of the drugs to be used
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: group serratus
preoperative superficial serratus block with local anaesthetics and parasternal block with saline
|
preoperativelly, Superficial Serratus Block performed with 30 ml %0.25 Bupivacaine and Parasternal Block performed with 10 ml saline
|
Active Comparator: group serratus and parasternal
preoperative superficial serratus block and parasternal block with local anaesthetics
|
preoperativelly, Superficial Serratus Block performed with 30 ml %0.25 Bupivacaine and Parasternal Block performed with 10 ml %0.25 Bupivacaine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative opioid consumption
Time Frame: first 24 hours
|
First 24 hours total fentanyl consumption with patient controlled analgesia
|
first 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensory Assessment
Time Frame: 24 hours
|
Sensory Assessment will be performed on patients following the block procedure with pinprick test.
|
24 hours
|
Visual analog pain score
Time Frame: First 24 hours
|
Post operative pain will be evaluated with a Visual Analogue Scale (between 0-10; 0: no pain, 10:worst pain) score
|
First 24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Hüsnü Kürşad, Ataturk University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hu NQ, He QQ, Qian L, Zhu JH. Efficacy of Ultrasound-Guided Serratus Anterior Plane Block for Postoperative Analgesia in Patients Undergoing Breast Surgery: A Systematic Review and Meta-Analysis of Randomised Controlled Trials. Pain Res Manag. 2021 Oct 25;2021:7849623. doi: 10.1155/2021/7849623. eCollection 2021.
- Piraccini E, Biondi G, Corso RM, Maitan S. The use of rhomboid intercostal block, parasternal block and erector spinae plane block for breast surgery. J Clin Anesth. 2020 Feb;59:10. doi: 10.1016/j.jclinane.2019.06.004. Epub 2019 Jun 6. No abstract available.
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 21, 2023
Primary Completion (Actual)
January 1, 2024
Study Completion (Actual)
January 15, 2024
Study Registration Dates
First Submitted
May 30, 2023
First Submitted That Met QC Criteria
June 21, 2023
First Posted (Actual)
June 22, 2023
Study Record Updates
Last Update Posted (Actual)
April 1, 2024
Last Update Submitted That Met QC Criteria
March 29, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ataunibreastanalgesia
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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