Pectoral Nerve Block Type-II and Rhomboid Intercostal Block for Pain Management Following Mastectomy Surgery

NCT04297007 | Completed

• 1 other identifier: Medipol Hospital 9
• Study Type: interventional
• Target: 90
• 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 pectoral nerve block (PECS) may be used for postoperative pain treatment following breast surgery. It is a novel interfascial block that was defined by Blanco. 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 opioid consumption and the secondary aim is to evaluate postoperative pain scores (VAS), adverse effects related with opioids (allergic reaction, nausea, vomiting).

Conditions

Breast Cancer; Breast Neoplasms; Breast Diseases; Breast Fibroadenoma

Keywords

Mastectomy and axillary dissection surgery; Pectoral nerve block; Rhomboid intercostal block; Postoperative pain management

Outcome Measures

Primary Outcomes (1)

• Opioid consumption

  The primary aim is to compare postoperative opioid consumption

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

Secondary Outcomes (1)

• Pain scores (Visual analogue scores-VAS)

  Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16 and 24 hours.

Study Arms (3)

Group P = PECS-II group

ACTIVE COMPARATOR

In group P, PECS will be performed with patients in the supine position at the end of the surgery before extubation by using US (Vivid Q, GE Healthcare, US). Under aseptic conditions the high frequency linear probe (11-12 MHz) will be covered with a sterile sheath and a 22G, 50 mm block needle will be used. US probe will be placed on the 4th rib. The muscles PMm, Pmm and Sam will be visualized. At the anterior axillary level or mid-axillary level, via the in-plane technique, Pecs II will be applied by injecting 20 mL of 0.25% bupivacaine in a cephalad to caudad direction to the fascia on Sam.

Other: PECS block

Group R = RIB group

ACTIVE COMPARATOR

In group R, RIB block will be performed with patients in the lateral decubitus position at the end of the surgery before extubation. 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 20 ml 0,25% bupivacaine will be injectted into the fascial plane.

Other: Rhomboid intercostal block

Group C = Control group

NO INTERVENTION

A dose of ibuprofen 400 mgr and tramodol 100 mg will be performed intraoperatively. 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.

Interventions

PECS block OTHER

A dose of ibuprofen 400 mgr and tramodol 100 mg will be performed intraoperatively. 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.

Group P = PECS-II group

Rhomboid intercostal block OTHER

A dose of ibuprofen 400 mgr and tramodol 100 mg will be performed intraoperatively. 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.

Group R = RIB group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• 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:

• history of bleeding diathesis,
• receiving anticoagulant treatment,
• known local anesthetics and opioid allergy,
• infection of the skin at the site of the needle puncture,
• pregnancy or lactation,
• patients who do not accept the procedure

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University Hospital

Istanbul, Bagcilar, 34070, Turkey (Türkiye)

Location

Related Publications (3)

• Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29.

  PMID: 22939099 BACKGROUND

• Karaca O, Pinar HU, Arpaci E, Dogan R, Cok OY, Ahiskalioglu A. The efficacy of ultrasound-guided type-I and type-II pectoral nerve blocks for postoperative analgesia after breast augmentation: A prospective, randomised study. Anaesth Crit Care Pain Med. 2019 Feb;38(1):47-52. doi: 10.1016/j.accpm.2018.03.009. Epub 2018 Apr 5.

  PMID: 29627431 BACKGROUND

• Tulgar S, Selvi O, Thomas DT, Manukyan M, Ozer Z. Rhomboid intercostal block in a modified radical mastectomy and axillary curettage patient; A new indication for novel interfascial block. J Clin Anesth. 2019 May;54:158-159. doi: 10.1016/j.jclinane.2018.12.006. Epub 2018 Dec 13. No abstract available.

  PMID: 30553225 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Breast Diseases; Fibroadenoma

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasms, Fibroepithelial; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial

Study Design

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

Model Details: There are three models for this study. Patients will be randomly divided into three groups (Group P = PECS group, Group R = RIB group, Group C = Control group), before entering the operating room.

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 5, 2020
• Study Start: March 23, 2020
• Primary Completion: January 20, 2021
• Study Completion: February 20, 2021
• Last Updated: April 2, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)