Comparison of Erector Spinae Plane Block and Serratus Posterior Superior Intercostal Plane Block

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06407037
• Other study ID #: AESH-EK1-2023-824
• Status: Recruiting
• Phase: N/A
• Start date: December 27, 2023
• Est. completion date: October 27, 2024

Study information

• Verified date: May 2024
• Source: Diskapi Yildirim Beyazit Education and Research Hospital
• Contact: Emine Arik, Associate Professor
• Phone: 05333471530
• Email: emineincearik[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: October 27, 2024
• Est. primary completion date: September 27, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Breast Neoplasms
• Erector Spinae Plane Block
• Postoperative Pain

Intervention

Procedure:
• Erector Spinae Plane Block
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.
• Serratus Posterior Superior Intercostal Plane Block
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.

Locations

Country	Name	City	State
Turkey	Ankara Etlik City Hospital	Yenimahalle	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Yildirim Beyazit Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative analgesia	Pain will be assessed with a 11 point numeric rating scale (0-10 whereas 0:no pain; 1-3: mild pain; 4-6: moderate pain and 7-10: severe pain)	Postoperative day 1
Secondary	Postoperative tramadol consumption	The amount of tramadol consumed in the postoperative period will be recorded	Perioperative day 1
Secondary	Postoperative nausea and vomiting (PONV)	PONV will be assessed with a 5 point PONV intensity scale (1-4 whereas 1:absence of PONV; 2: nausea present, vomiting absent; 3 nausea present, vomiting once; 4: nausea present vomiting twice or more	Postoperative day 1
Secondary	Patient satisfaction	Satisfaction will be assessed with a 5 point Likert scale (0-4 whereas 0:definitely disagree; 1:slightly agree; 3: agree; 4: strongly agree)	Postoperative 24th hour