ESPB and RIB for Pain Management Following Mastectomy Surgery

Breast Cancer Clinical Trial

Official title:

Comparison of Ultrasound-Guided Erector Spinae Plane Block and Rhomboid Intercostal Block for Pain Management Following Mastectomy Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04752150
• Other study ID #: Medipol Hospital 18
• Status: Completed
• Phase: N/A
• Start date: February 16, 2021
• Est. completion date: December 20, 2021

Study information

• Verified date: January 2022
• Source: Medipol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Postoperative pain is an important issue in patients underwent mastectomy and axillary dissection 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 novel interfascial block that was defined by Forero. Rhomboid intercostal block (RIB) is a novel block and was first described by Elsharkawy et al. Local anesthetic solution is administrated between the rhomboid muscle and intercostal muscles over the T5-6 ribs. It has been reported that RIB may provide effective analgesia management for several breast surgeries.

The primary aim of the study is to compare postoperative pain scores (VAS), and the secondary aim is to evaluate postoperative opioid consumption, adverse effects related with opioids (allergic reaction, nausea, vomiting).

Description:

Postoperative pain is an important issue in patients underwent mastectomy and axillary dissection surgery. Postoperative effective pain treatment provides early mobilization and shorter hospital stay, thus complications due to hospitalization such as infection and thromboembolism may be reduced.

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. Rhomboid intercostal block (RIB) is a novel block and was first described by Elsharkawy et al. Local anesthetic solution is administrated between the rhomboid muscle and intercostal muscles over the T5-6 ribs 2-3 cm medially of the medial border of the scapula. RIB targets both the posterior rami and lateral cutaneous branches of the thoracic nerves and provides analgesia for the hemithorax from T2 to T9. It has been reported that RIB may provide effective analgesia management for several breast surgeries.

The US-guided erector spina plane block (ESPB) is defined by Forero et al. 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 evaluate the efficacy of the US-guided ESPB and RIB for postoperative analgesia after mastectomy and axillary dissection surgery. The primary aim is to compare postoperative pain scores (VAS), and the secondary aim is to evaluate opioid consumption, adverse effects related with opioids (allergic reaction, nausea, vomiting).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 20, 2021
• Est. primary completion date: December 20, 2021
• 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:

• receiving anticoagulant treatment,

• known study drugs allergy,

• opioid addiction

• infection of the skin at the site of the block,

• pregnancy or lactation,

Related Conditions & MeSH terms

• Breast Cancer
• Breast Cancer Female
• Breast Neoplasms

Intervention

Other:
• Analgesia management; group ESPB and RIB
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 (5)

Altiparmak B, Korkmaz Toker M, Uysal AI, Dere Ö, Ugur B. Evaluation of ultrasound-guided rhomboid intercostal nerve block for postoperative analgesia in breast cancer surgery: a prospective, randomized controlled trial. Reg Anesth Pain Med. 2020 Apr;45(4):277-282. doi: 10.1136/rapm-2019-101114. Epub 2020 Feb 19. — View Citation

Ciftci B, Ekinci M, Celik EC, Tukac IC, Bayrak Y, Atalay YO. Efficacy of an Ultrasound-Guided Erector Spinae Plane Block for Postoperative Analgesia Management After Video-Assisted Thoracic Surgery: A Prospective Randomized Study. J Cardiothorac Vasc Anesth. 2020 Feb;34(2):444-449. doi: 10.1053/j.jvca.2019.04.026. Epub 2019 Apr 30. — View Citation

Elsharkawy H, Saifullah T, Kolli S, Drake R. Rhomboid intercostal block. Anaesthesia. 2016 Jul;71(7):856-7. doi: 10.1111/anae.13498. — View Citation

Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451. — View Citation

Gürkan Y, Aksu C, Kus A, Yörükoglu UH, Kiliç CT. Ultrasound guided erector spinae plane block reduces postoperative opioid consumption following breast surgery: A randomized controlled study. J Clin Anesth. 2018 Nov;50:65-68. doi: 10.1016/j.jclinane.2018.06.033. Epub 2018 Jul 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain scores (Visual analogue scores-VAS)	The primary aim is to compare 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.
Secondary	Opioid consumption	The secondary aim is to compare postoperative opioid consumption	Change from baseline opioid consumption at postoperative 1, 2, 4, 8, 16, and 24 hours