Different Volumes of Erector Spinae Plane Block for Breast Surgery

Breast Cancer Clinical Trial

Official title:

Erector Spinae Plane Block in Different Volumes on Postoperative Pain Control Following Breast Surgery: A Randomized, Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05232084
• Other study ID #: Medipol Hospital 26
• Status: Completed
• Phase: N/A
• Start date: January 27, 2022
• Est. completion date: May 25, 2023

Study information

• Verified date: May 2023
• Source: Medipol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 25, 2023
• Est. primary completion date: May 20, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Diseases
• Breast Neoplasms

Intervention

Drug:
• Bupivacaine + Fentanyl
Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit. Postoperative patient evaluation will be performed by an anesthesiologist blinded to the procedure.

Locations

Country	Name	City	State
Turkey	Istanbul Medipol University Hospital	Istanbul	Bagcilar

Sponsors (1)

Lead Sponsor	Collaborator
Medipol University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Altiparmak B, Korkmaz Toker M, Uysal AI, Gumus Demirbilek S. Comparison of the efficacy of erector spinae plane block performed with different concentrations of bupivacaine on postoperative analgesia after mastectomy surgery: ramdomized, prospective, double blinded trial. BMC Anesthesiol. 2019 Mar 4;19(1):31. doi: 10.1186/s12871-019-0700-3. — View Citation

Gurkan Y, Aksu C, Kus A, Yorukoglu UH. Erector spinae plane block and thoracic paravertebral block for breast surgery compared to IV-morphine: A randomized controlled trial. J Clin Anesth. 2020 Feb;59:84-88. doi: 10.1016/j.jclinane.2019.06.036. Epub 2019 Jul 4. — View Citation

Sharma S, Arora S, Jafra A, Singh G. Efficacy of erector spinae plane block for postoperative analgesia in total mastectomy and axillary clearance: A randomized controlled trial. Saudi J Anaesth. 2020 Apr-Jun;14(2):186-191. doi: 10.4103/sja.SJA_625_19. Epub 2020 Mar 5. — View Citation

Uda Y, Byrne K, Brahmbhatt A, Gotmaker R, Lim D, Konishi Y, Eves TK, Paxton E, Barrington MJ. A pilot randomized-controlled trial evaluating the erector spinae plane block in thoracic and breast surgery. Can J Anaesth. 2020 Oct;67(10):1371-1380. doi: 10.1007/s12630-020-01759-5. Epub 2020 Jul 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative opioid consumption (need and demand as microgram)	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	Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.
Secondary	Pain scores (Visual analogue scores-VAS)	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	Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16 and 24 hours