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Trial Title:
Comparison of Erector Spinae Plane Block and Serratus Posterior Superior Intercostal Plane Block
NCT ID:
NCT06407037
Condition:
Erector Spinae Plane Block
Serratus Posterior Superior Intercostal Plane Block
Acute Pain
Postoperative Pain
Breast Neoplasms
Conditions: Official terms:
Breast Neoplasms
Acute Pain
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Procedure
Intervention name:
Erector Spinae Plane Block
Description:
Erector Spinae Plane Block will be performed unilaterally, under US guidance, before the
surgical operation, when the patient is placed in the prone position. 30 ml of 0.25%
bupivacaine will be used in applications.
Arm group label:
Erector Spinae Plane Block
Intervention type:
Procedure
Intervention name:
Serratus Posterior Superior Intercostal Plane Block
Description:
Serratus Posterior Superior Intercostal Plane Block will be performed unilaterally, under
US guidance, before the surgical operation, when the patient is placed in the prone
position. 30 ml of 0.25% bupivacaine will be used in applications.
Arm group label:
Serratus Posterior Superior Intercostal Plane Block
Summary:
Breast cancer is the most common malignancy in women. Modified radical mastectomy, a
surgical procedure in the treatment of breast cancer, is one of the standard treatments.
Postoperative pain can seriously reduce the quality of life in patients, and inadequately
treated acute pain can trigger chronic pain syndrome. Therefore, thoracic paravertebral
block and thoracic epidural block are effective in postoperative analgesia. However, the
use of these blocks is limited due to complications. In recent years, less invasive
blocks, such as pectoral nerve block (PECS I-II), Serratus anterior plane block (SAPB),
Erector spinae plane block (ESPB), and Serratus Posterior Superior intercostal Plane
Block (SPSİPB) have been applied. In this study, it was aimed to compare the analgesic
effectiveness of ESPB and SPSİPB applications in patients undergoing breast surgery.
Detailed description:
Postoperative pain will be assessed during resting and coughing with a Numeric Pain Scale
(NRS) and nausea and vomiting with a Postoperative Nausea Vomiting Score at the
postoperative 1, 4, 8, 12, and 24 hours. The amount of tramadol consumed in the
postoperative period will be recorded. Patient satisfaction will be assessed with the
Likert scale at postoperative 24 hours.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Those aged 18-65
- Those with ASA scores I-II-III
- Those with a body mass index (BMI) between 18-35
- Patients who will undergo modified radical mastectomy
Exclusion Criteria:
- Those under the age of 18 and over the age of 65
- Those with ASA score IV and above
- Those with a history of allergy to the drugs to be blocked
- Those with a history of bleeding diathesis
- Patients with infection in the area to be blocked
- Those with a BMI below 18 and above 35
- Patients who underwent surgery under emergency conditions
Gender:
Female
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Ankara Etlik City Hospital
Address:
City:
Yenimahalle
Zip:
06170
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Emine Arık, Associate Professor
Phone:
05333471530
Email:
emineincearik@yahoo.com
Contact backup:
Last name:
Musa Zengin, Associate Professor
Phone:
05307716235
Email:
musazengin@gmail.com
Start date:
December 27, 2023
Completion date:
October 27, 2024
Lead sponsor:
Agency:
Diskapi Yildirim Beyazit Education and Research Hospital
Agency class:
Other
Source:
Diskapi Yildirim Beyazit Education and Research Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06407037
