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Clinical Trials/NCT06407037
NCT06407037CompletedNot Applicable

Comparison of the Effects of Ultrasound-Guided Erector Spinae Plane Block and Serratus Posterior Superior Intercostal Plane Block on Postoperative Acute Pain in Patients Undergoing Breast Surgery

Diskapi Yildirim Beyazit Education and Research Hospital2 sites in 2 countries50 target enrollmentStarted: December 27, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
50
Locations
2
Primary Endpoint
Postoperative analgesia

Study Overview

Brief 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 visual analog scale (0-10 cm) 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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 breast surgery

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

Outcomes

Primary Outcomes

Postoperative analgesia

Time Frame: Postoperative day 1

Pain will be assessed with a visual analog scale (0-10 cm)

Secondary Outcomes

  • Postoperative tramadol consumption(Perioperative day 1)
  • Patient satisfaction(Postoperative 24th hour)

Investigators

Sponsor
Diskapi Yildirim Beyazit Education and Research Hospital
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Emine Arik

Principal İnvestigator

Ankara Etlik City Hospital

Study Sites (2)

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