- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06381765
Serratus Plane Block and Pectointercostal Block
May 10, 2024 updated by: ebru biricik, Cukurova University
Comparison of Deep Serratus Plane Block With Deep Serratus Plane Block+Pectointercostal Plane Block
ASA I-II female patients aged over 18 who will undergoing breast reduction surgery will recruit to the study.
Patients will divide into 2 groups.
Deep serratus plane block will perform with 0,25 %bupivacaine 20 ml at the midaxillary 5. rib, bilaterally for Group I.
At Group II, deep serratus plane block ( 0,25 %bupivacaine 20 ml) at the midaxillary 5.th rib+ pectointercostal plane block (0,25% bupivacaine 15 ml) at 4-5.th intercostal space will perform bilaterally .
General anesthesia with sevoflurane and remifentanil will perform to the all patients.
Postoperative pain scores, morphine consumption and complications will record till the 24.th hours.
Study Overview
Status
Recruiting
Conditions
Detailed Description
ASA I-II female patients aged over 18 who will undergoing breast reduction surgery will recruit to the study.
General anesthesia with sevoflurane and remifentanil will perform to the all patients.
Patients will divide into 2 groups.
Serratus plane block for group I and serratus plane block+pectointercostal block for Group II will perform bilaterally.
Ultrasound guided deep serratus plane block will perform with 0,25% bupivacaine 20 ml at the midaxillary 5. rib, for Group I.
At Group II, ultrasound guided deep serratus plane block ( 0,25 %bupivacaine 20 ml) at the midaxillary 5.th rib+ pectointercostal plane block (0,25% bupivacaine 15 ml) at 4-5.th intercostal space will perform bilaterally.
Patient controlled analgesia will perform with Morphine ( 1 mg bolus+ 10 min lockout+4 hours limit 10 mg) at postoperative period.
Patients will evaluate with visual analogue scale (VAS) for postoperative pain scores till the first 24.th
hours.
Postoperative pain scores (VAS), morphine consumption and complications will record till the 24.th hours.
Study Type
Interventional
Enrollment (Estimated)
60
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: Ebru Biricik
- Phone Number: 05052420223
- Email: ebrubiricik01@gmail.com
Study Locations
-
-
-
Adana, Turkey
- Recruiting
- Cukurova University Faculty of Medicine
-
Contact:
- Ebru Biricik
- Phone Number: 05052420223
- Email: ebrubiricik01@gmail.com
-
-
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:
- ASA I-II patients
- Female
- who will undergoing Breast reduction surgery
Exclusion Criteria:
- ASA III and over patients
- who reject to join the study
- male gender
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Serratus plane block
Deep serratus plane block will perform with 20 ml 0,25 %bupivacaine at the midaxillary 5. rib, bilaterally
|
ultrasound guided serratus plane block (20 ml 0,25 %bupivacaine) will perform at the midaxillary 5.th rib to the all patients
|
|
Active Comparator: Serratus plane block+pectointercostal plane block
deep serratus plane block (20 ml 0,25 %bupivacaine) at the midaxillary 5.th rib+ pectointercostal plane block (0,25% bupivacaine 15 ml) at 4-5.th intercostal space will perform bilaterally .
|
ultrasound guided serratus plane block (20 ml 0,25 %bupivacaine) will perform at the midaxillary 5.th rib and pectointercostal plane block (0,25% bupivacaine 15 ml) will perform at 4-5.th intercostal space.
Both 2 blocks will perform bilaterally
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
postoperative morphine consumption
Time Frame: All the patients will follow till the postoperative 24.th hours and totally morphine consumption will record postoperative 24.th hours.
|
Patient controlled analgesia with morphine will perform to the all patients and morphine consumption will calculate and record till the end of 24.th hours.
|
All the patients will follow till the postoperative 24.th hours and totally morphine consumption will record postoperative 24.th hours.
|
|
postoperative visual analog scale scores
Time Frame: VAS scores will record at the first postoperative 24.th hours
|
All the patients will evaluate with visual analog scale scores (VAS) at the first postoperative 24.th hours period.
VAS scores will define between 0-10 scores.
0 score means lowest pain score and 10 means the worst pain score.
|
VAS scores will record at the first postoperative 24.th hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ebru Biricik, Cukurova University Faculty of Medicine
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)
May 10, 2024
Primary Completion (Estimated)
August 10, 2024
Study Completion (Estimated)
August 10, 2024
Study Registration Dates
First Submitted
April 19, 2024
First Submitted That Met QC Criteria
April 19, 2024
First Posted (Actual)
April 24, 2024
Study Record Updates
Last Update Posted (Actual)
May 13, 2024
Last Update Submitted That Met QC Criteria
May 10, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Serratus-Pectointercostal
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
product manufactured in and exported from the U.S.
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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