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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06381765
Other study ID # Serratus-Pectointercostal
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 10, 2024
Est. completion date August 10, 2024

Study information

Verified date May 2024
Source Cukurova University
Contact Ebru Biricik
Phone 05052420223
Email ebrubiricik01@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date August 10, 2024
Est. primary completion date August 10, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
ultrasound guided Serratus plane bock and pectointercostal block
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
ultrasound guided Serratus plane bock
ultrasound guided serratus plane block (20 ml 0,25 %bupivacaine) will perform at the midaxillary 5.th rib to the all patients

Locations

Country Name City State
Turkey Çukurova University Faculty of Medicine Adana

Sponsors (1)

Lead Sponsor Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary postoperative morphine consumption 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.
Primary postoperative visual analog scale scores 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
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