Clinical trial NCT04297007: Pectoral Nerve Block Type-II and Rhomboid Intercostal Block for Pain Management Following Mastectomy Surgery
Official title: Comparison of Ultrasound-Guided Type-II Pectoral Nerve Block and Rhomboid Intercostal Block for Pain Management Following Mastectomy Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Breast Neoplasms
Breast Diseases
Breast Fibroadenoma
Keywords: Mastectomy and axillary dissection surgery
Pectoral nerve block
Rhomboid intercostal block
Postoperative pain management
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2020-03-05
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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).

Detailed 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. 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. It is easy to perform; under ultrasound (US) guidance, the interfascial region between the pectoral muscles (pectoralis major (PMm) and minor (Pmm), serratus anterior Sam) is injected with local anaesthetics. It has been reported that PECS type-2 block provides effective analgesia management for mastectomy and axillary dissection surgeries.

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 aim of this study is to evaluate the efficacy of the US-guided PECS-II and RIB for postoperative analgesia management compare to no intervention control group after mastectomy and axillary dissection surgery. The primary aim 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).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Opioid consumption
timeFrame: Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.
Secondary outcomes:
measure: Pain scores (Visual analogue scores-VAS)
timeFrame: Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16 and 24 hours.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University Hospital
state: Bagcilar
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.