Different Volumes of Erector Spinae Plane Block for Breast Surgery

Not Applicable

Completed

• Conditions: Breast Cancer; Breast Diseases; Breast Neoplasms
• Interventions: Drug: Bupivacaine + Fentanyl

• Registration Number: NCT05232084
• Lead Sponsor: Medipol University

Brief Summary

Postoperative pain is an important issue in female patients underwent breast surgery. Postoperative effective pain treatment provides early mobilization and shorter hospital stay. The US-guided erector spina plane block (ESPB) may be used for postoperative pain treatment following breast surgery. It is a relatively novel interfascial block that was defined by Forero et al. It has been reported that ESPB provides effective analgesia management for several breast surgeries.

Detailed Description

Various methods may be performed to reduce the use of systemic opioids and for effective pain treatment following mastectomy and axillary dissection surgery. Ultrasound (US)-guided interfascial plane blocks have been used increasingly due to the advantages of ultrasound in anesthesia practice.

The US-guided erector spina plane block (ESPB) provides thoracic analgesia at T5 level and abdominal analgesia at T7-9 level. ESPB contains a local anesthetic injection into the deep fascia of erector spinae. Visualization of sonoanatomy is easy, and the spread of local anesthesic agents can be easily seen under the erector spinae muscle. Thus, analgesia occurs in several dermatomes with cephalad-caudad way. In the literature, it has been reported that ESP block provides effective analgesia after several surgeries such as open heart surgery, breast surgery, thoracoscopic and abdominal operations.

The aim of this study is to compare the efficacy of the different volumes of US-guided ESPB for postoperative analgesia after mastectomy and axillary dissection surgery. The primary aim is to compare postoperative opioid consumption, and the secondary aim is to evaluate pain scores (VAS), and adverse effects related with opioids (allergic reaction, nausea, vomiting).

Study Timeline

• Study First Submitted: 2022-01-14
• Study Start: 2022-01-27
• Study First Submitted QC: 2022-02-08
• Study First Posted: 2022-02-09
• Status Verified: 2023-05
• Primary Completion: 2023-05-20
• Study Completion: 2023-05-25
• Last Update Submitted: 2023-05-26
• Last Update Posted: 2023-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• American Society of Anesthesiologists (ASA) classification I-II
• Scheduled for mastectomy and axillary dissection surgery under general anesthesia

Exclusion Criteria

• anticoagulant treatment,
• known local anesthetic allergy,
• infected skin around the block site,
• pregnancy or breast-feeding,
• back abnormalities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 30 = 30 ml of Erector spinae plane block group	Bupivacaine + Fentanyl	In group 30 ml, ESPB will be performed with patients in the lateral decubitus position while the surgical site up. US probe will be placed 2-3 cm lateral to the T4 transvers process. The block needle will be inserted cranio-caudal direction and then for correction of the needle 5 ml saline will be injected deep into the erector spina muscle fascia. Following confirmation of the correct position of the needle 30 ml %0.25 bupivacaine will be administered for block.
Group 20 = 20 ml of Erector spinae plane block group	Bupivacaine + Fentanyl	In group ESPB, ESPB will be performed with patients in the lateral decubitus position while the surgical site up. US probe will be placed 2-3 cm lateral to the T4 transvers process. The block needle will be inserted cranio-caudal direction and then for correction of the needle 5 ml saline will be injected deep into the erector spina muscle fascia. Following confirmation of the correct position of the needle 20 ml %0.25 bupivacaine will be administered for block.

Primary Outcome Measures

Name	Time	Method
Postoperative opioid consumption (need and demand as microgram)	Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.	The primary aim is to compare postoperative opioid (fentanyl) consumption on patient controlled analgesia device.; The parameters on PCA devices such as delivery and demand will be assessed

Secondary Outcome Measures

Name	Time	Method
Pain scores (Visual analogue scores-VAS)	Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16 and 24 hours	Postoperative pain assessment will be performed using the VAS score (0 = no pain, 10 = the most severe pain felt). The VAS scores will be recorded

Trial Locations

Locations (1)

Istanbul Medipol University Hospital; 🇹🇷 Istanbul, Bagcilar, Turkey