ESPB and RIB for Pain Management Following Mastectomy Surgery

NCT04752150 | Completed

• 1 other identifier: Medipol Hospital 18
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Breast Cancer; Breast Neoplasms; Breast Cancer Female

Keywords

Mastectomy and axillary dissection surgery; Postoperative pain management; Rhomboid intercostal block; Erector spina plane block

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Opioid consumption

  Change from baseline opioid consumption at postoperative 1, 2, 4, 8, 16, and 24 hours

Study Arms (2)

Group ESPB = Erector spinae plane block group

ACTIVE COMPARATOR

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 30 ml %0.25 bupivacaine will be administered for block.

Other: Analgesia management; group ESPB and RIB

Group RIB = RIB group

ACTIVE COMPARATOR

In group RIB, RIB block will be performed with patients in the lateral decubitus position while the surgical site up. The linear high frequency probe will be placed in sagittal plane medially on the medial border of the scapula at T5-6 level. The trapezius muscle, rhomboid major muscle, intercostal muscle, ribs and the pleura will be visualized. The needle will be inserted into the fascial plane between the rhomboid major and intercostal muscles in a cranio-caudal direction. A dose of 30 ml 0,25% bupivacaine will be injectted into the fascial plane.

Other: Analgesia management; group ESPB and RIB

Interventions

Analgesia management; group ESPB and RIB OTHER

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.

Group ESPB = Erector spinae plane block group; Group RIB = RIB group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Female patients who will undergo breast surgery will be included
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• receiving anticoagulant treatment,
• known study drugs allergy,
• opioid addiction
• infection of the skin at the site of the block,
• pregnancy or lactation,

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University Hospital

Istanbul, Bagcilar, 34070, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 27501016 BACKGROUND

• 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.

  PMID: 31122843 BACKGROUND

• Gurkan Y, Aksu C, Kus A, Yorukoglu UH, Kilic 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.

  PMID: 29980005 BACKGROUND

• Elsharkawy H, Saifullah T, Kolli S, Drake R. Rhomboid intercostal block. Anaesthesia. 2016 Jul;71(7):856-7. doi: 10.1111/anae.13498. No abstract available.

  PMID: 27291611 BACKGROUND

• Altiparmak B, Korkmaz Toker M, Uysal AI, Dere O, 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.

  PMID: 32079739 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The anesthesiologist who performs postoperative pain evaluation and the patient will not know the group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary researcher

Model Details: There are two models for this study. The first group is ESPB group. The second one is RIB group

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 12, 2021
• Study Start: February 16, 2021
• Primary Completion: December 20, 2021
• Study Completion: December 20, 2021
• Last Updated: January 21, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)